maude fda product code

Baseline brand name All "FLAG" data elements have the value of "Y" for Yes, "N" for No, or are blank if no data was available/entered. Previous Use Code (H8) 03 Literature MAUDE Alerts by Innolitics. 613 MRI CENTERS 405 SERVICE PERSONNEL 509 OUTPATIENT CLINIC/SURGERY Adverse Event Flag (B1) 810 PATIENT'S HOME Master Event Data: A distinct master event data record will be present for each source reporting an event. MAUDE data does not represent all known safety information for a reported medical device and should be interpreted in the context of other available information when making device-related or treatment decisions. Manufacturer and User Facility Device Experience (MAUDE) database represents reports of adverse events involving medical devices. 106 NUCLEAR MEDICINE TECHNOLOGIST N = No Date Removed Flag -- D7, new added; 2006; if flag in M or Y, print Date, U = Unknown 510K Number. The MAUDE database houses medical device reports submitted to the FDA by mandatory reporters 1 (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers. 4. 307 PERSONAL CARE ASSISTANT NA NOT APPLICABLE Example 1: Food Product Code Product: Canned Tomato Soup (Concentrated) Product Code: 38BEE27 Example 2: Drug Product Code Product: Ibuprofen Product Code: 62GBA41 Example 3:. S - Disability UDI-Public (D4) 17. 400 SERVICE AND TESTING PERSONNEL Manufacturer. Product Code Builder Tutorial: The Product Code Builder Tutorial gives you the information you need to successfully code products. Product Code: Review Panel . 116 DENTIST This does not replace the current online Product Code Builder but compliments it by providing trade a method to program existing software to query and verify FDA Product Codes. 51. Distributor Address line 1 (F3) Distributor Address line 2 (F3) By building upon the code portions you select, the application will provide you with choices for each of the five components of the product code (Industry, Class, Subclass, PIC, and Product). If a report contains trade secret or confidential business information, that text is replaced by "(b)(4)". 102 DENTAL HYGIENIST Manufacturer Contact Title Name (G1) MD 20993 Ph. 20. Date Manufacturer Received (G4), SECTION-H 3. Brand Name (D1) 64. Subclass Code: This element is one letter (a-z) and represents the container type, method of application, use, market class or material the product is being packaged in. Manufacturer Contact Street 2 (G1) Device Availability (D10), Y = Yes 30. 2. In other words, if a User Facility, Distributor, Manufacturer, and voluntary submitter all report an event, there will be four event records. R - Required Intervention The designations "(b)(4)" and "(b)(6)" refer to the exemptions in the FOIA. Industry Code: This element is two numbers from "02" to "98. An industry code determines the broadest area into which a product falls. This is updated every Sunday and can be found here:- Download Product Code Classification Files The information is held in a 'zip' file which when de-compressed is a txt file called 'foiclass.txt' In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use. Language Assistance Available: Espaol | | Ting Vit | | Tagalog | | | Kreyl Ayisyen | Franais | Polski | Portugus | Italiano | Deutsch | | | English, The MAUDE database houses medical device reports submitted to the FDA by mandatory reporters, CDRH Export Certificate Validation (CECV), Radiation-Emitting Electronic Products Corrective Actions, Instructions for Downloading Viewers and Players. The CDRH database links medical devices to the appropriate regulation that contains a product definition and is published in Title 21, Code of Federal Regulations. 2. R = Device was returned to manufacturer For example, "(b)(4)" may be found in place of the product's composition and "(b)(6)" may be found in place of a patient's age. Baseline other id no Baseline PMA flag 45. 19. 4. The Product Classification Database contains medical device names and associated information developed by the Center for Devices and Radiological Health (CDRH) in support of its mission. MAUDE is updated monthly and the search page reflects the date of the most recent update. 26. The name and product code identify the generic category of a device for FDA. Process Indicator Code (PIC): This element is one letter (a-z) and describes the process, storage or dosage form depending on the type of product. 34. I = No information at this time The purpose of this application is to make the MAUDE FDA database easier to search for device manufacturers, practitioners, and patients. 79. 820 IN TRANSIT TO USER/MEDICAL FACILITY For this data to be meaningful, you should download all four types of files. FiberStitch Implant, Curved With Two Polyester Implants And 2-0 FiberWire, FiberStitch Implant, Straight With Two Polyester Implants And 2-0 FiberWire. Note: If you need help accessing information in different file formats, see Model Number. Foundation Dermal Regeneration Scaffold (DRS) Solo. Product Code. F = Followup 37. Each year, the FDA receives several hundred thousand. Date Report to FDA (F11) Searches only retrieve records that contain the search term(s) provided by the requester. The FDA uses MDRs to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. * - Invalid Data 113 RADIOLOGIC TECHNOLOGIST The word "OTHER" may appear as one of the values if the "Other" box was checked off. If the whole field is blank, no data was reported/entered. Manufacturer Contact Postal Code 7. For these files to be useful to you, you'll first have to download them, unzip them, and then import them into a database or word processor for your further processing. D - Death. Manufacturer Address 2 (D3) The site is secure. Baseline date ceased marketing. 700 LONG-TERM CARE FACILITY K213485: Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D And AOJ-25E: Shenzhen AOJ Medical Technology Co., Ltd. K213079: Ear Thermometer, Model ET001 4 5 49 records meeting your search criteria returned- Product Code: QAU Patient Problem: Gastrointestinal Hemorrhage: New Search Export to Excel | Help. The name and product code identify the generic category of a device for FDA. 33. Section G CONTACT address information may not necessarily be the address where the device is manufactured. Baseline 510(k exempt flag 115 SPEECH THERAPIST 21. The submission of an MDR itself is not evidence that the device caused or contributed to the adverse outcome or event. PMA PMN Number Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. If the database does not. 100 OTHER HEALTH CARE PROFESSIONAL 403 MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE N = No Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. The four record formats contain all releasable information on MEDWATCH Form 3500. Date Report to Manufacturer (F13), SECTION-G (only for report source 'M', others sources will be null), 23. 8. X = Extra copy received The designations "(b)(4)" and "(b)(6)" refer to the exemptions in the FOIA. MAUDE Patient records received to date for 2022. * = Invalid Data, 54. FDA Receipt Date . Baseline PMA no Manufacturer Contact State Code (G1) For medical devices, the product (group) element is two letters and when used in conjunction with the class element, identifies a specific medical device. Event type (H1) -- only relevant for report sourcetype 'M', D = Death Search FDA . The .gov means its official.Federal government websites often end in .gov or .mil. Report Number Data more than 10 years old through 1995 is available in zip files as listed below by year. U = User Facility report 503 DIALYSIS UNIT C - Congenital Anomaly 80. For . 39. 600 AMBULATORY HEALTH CARE FACILITY FOS. 107 OCCUPATIONAL THERAPIST 13. When in doubt, you may wish to contact the manufacturer for processing information. Manufacturer. Distributor Name (F3) -- if report source code = 'M' and The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Product Code. MAUDE - Manufacturer and User Facility Device Experience. UNK UNKNOWN, SECTION-E (if source code is 'P', Section E to H will contain no data), 15. Device Evaluated by Manufacturer (H3), Y = Yes add to cart $25. When you file a MDR, the adverse event will be entered into the MAUDE databased. Catalog Number (D4) 302 HOME HEALTH AIDE 2 NURSE Device not returned to manufacturer. Date Received, 9. 004 OUTPATIENT TREATMENT FACILITY (MAUDE) Device Name. The data consists of voluntary. M = Manufacturer report, 5. Manufacturer: Brand Name . 30. Distributor Zip Code Ext (F3) organic. New MAUDE Narrative data for the current month. 47. Medwatch: Where you can submit your MDR report on-line. NI NO INFORMATION 101 AUDIOLOGIST Number Devices in Event (if source code is 'P', field will be null) 27. RL = Replace 608 DRUG CLINIC, 609 IMAGING CENTER - MOBILE 59. 2 3 > 28 records meeting your search criteria returned- Product Code: JIF Patient Problem: No Known Impact Or Consequence To Patient: New Search Export to Excel | Help. MD 20993 Ph. 16. 21. MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. 61. RP = Repair Reporter Occupation Code (E3) -- new added, 2006, * INVALID DATA It also lets you save searches and receive emails when new events match. 29. 12. 65. 3. If a report contains personnel or medical files information, that text is replaced by "(b)(6)". 836 STREET Date Received (from mdr_document table) A - Not Applicable 13. Manufacturer Contact Phone No (G2) FDA Home . MAUDE - Manufacturer and User Facility Device Experience . K221731. To Search by Brand Name, Manufacturer, Event Type, 510K Number, PMA Number, Product Code, or date, select. 604 CATHETERIZATION LAB - FREE STANDING The downloadable data files consist of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. 42. What resources are available to help me create a product code? Date Added U.S. Food & Drug Administration Follow FDA; En Espaol; Search FDA . NI NO INFORMATION 833 PLAYGROUND Please note that the MAUDE web search feature is limited to adverse event reports within the past 10 years. 000 OTHER Remedial Action (H7) -- multiple source type, separate by ',', RC = Recall Please see the MDR Data Files webpage for Device Experience Network (DEN) and Alternative Summary Report (ASR) data received by the FDA. 15. O - Other Manufacturer Address line 1 (F14) 001 PHYSICIAN 46. O = Other 1. Manufacturer Address line 2 (F14) MAUDE - Manufacturer and User Facility Device Experience. 002 NURSE 1. UNK UNKNOWN, An official website of the United States government, : The .gov means its official.Federal government websites often end in .gov or .mil. Device Sequence No -- from device report table This database contains device names and their associated product codes. Baseline model no The adverse event meets the requirement of MDR Reportable. Initial Report to FDA (E4), Y = Yes Device Problem Code Product: First Aid Kit including drugs 81. All results are from the MAUDE database. silicone. Establishing a cause-and-effect relationship is especially difficult if circumstances surrounding the event have not been verified or if the device in question has not been directly evaluated. 1 2 11 records meeting your search criteria returned- Product Code: LBI Patient Problem: No Consequences Or Impact To Patient . 703 PSYCHIATRIC FACILITY Manufacturer Name. Product: Canned Tomato Soup (Concentrated) Report Number. The Product Code assigned to a device is based upon the medical device . 504 EMERGENCY ROOM MAUDE: FDA database of adverse event reports. The .gov means its official.Federal government websites often end in .gov or .mil. Manufacturer State Code (F14) Note: If you need help accessing information in different file formats, see 32. The product code submitted with each FDA line item should match the actual product name and/or invoice description of the product. Medical Device Reports (MAUDE) CDRH Export Certificate Validation (CECV) CDRH FOIA Electronic Reading Room; CFR Title 21; CLIA; . Search My Alerts. Manufacturer G1 City (G1) Manufacturer Contact Zip Code (G1) Certain types of report information are protected from public disclosure under the Freedom of Information Act (FOIA). Manufacturer G1 State Code (G1) Baseline shelf life in months Y = Year provided only, day defaulted to 01, month defaulted to January, 5. 112 PHYSICIAN ASSISTANT Date Report (from mdr_text table) Search My Alerts. 402 HOSPITAL SERVICE TECHNICIAN PM = Patient Monitoring 005 OUTPATIENT DIAGNOSTIC FACILITY 10. Manufacturer Address 1 (D3) Device Code . 102 DENTAL HYGIENIST FDA Home; Medical Devices; Databases - 510(k) | . 605 CHEMOTHERAPY CENTER The Product Code Builder has helpful tips to assist in building a product code. 23 SUS contains both MedWatch and MedSun adverse event reports. The Product Code assigned to a device is based upon the medical device product classification designated under 21 CFR Parts 862-892." The documentation describes the data fields. Date of Event (B3) -- new added, 2006 500 HOSPITAL Expiration Date of Device (D4) The string of letters and numbers represents five components: Industry Code, Class, Subclass, Process Indicator Code (PIC), and the Product (Group). Problem Description, PATIENTPROBLEMCODE contains following 2 fields, delimited by pipe (|), one record per line: 111 PHYSICAL THERAPIST New MAUDE Base records for the current month. Patient Problem Code, * INVALID DATA Manufacturer Name (D3) Device data updates: changes to existing Device data and additional Device data for existing Base records. . For example, "(b)(4)" may be found in place of the product's composition and "(b)(6)" may be found in place of a patient's age. A = Not applicable The name and product code identify the generic category of a device for FDA. 117 NURSE PRACTIONER, * INVALID DATA Bionova Medical Inc. K210718. All text fields contain whatever data was provided/entered. The searchable database data contains the last 10 years of. D = Distributor report Product Code Builder Application Programming Interface (API): The Product Code Builder API is a web service that provides the capability for software programmers to build a user interface that retrieves information from the Product Code Builder database. 0LP LAY USER/PATIENT Manufacturer G1 Postal Code IJ = Injury . Health Professional (E2) Manufacturer Contact Phone No Ext (G2) Instructions for Downloading Viewers and Players. Light, Surgical, Ceiling Mounted . naturally hydrating, aloe- and water-based personal lubricant. IN = Inspection Product Code: KDI Model Number: UNKNOWN-2008 Product Problem(s): . It contains seven lessons. If the product has more than one name (e.g., a fish known under several regional names), the product code may have several different synonymous definitions associated with it. The easiest way to determine the product code is to become familiar with the product itself, including the label, the processing information, intended use of product, the container type, who will use or consume the product, etc. Distributor City (F3) The MAUDE database houses MDRs submitted to the FDA by mandatory reporters 1 (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers. Before sharing sensitive information, make sure you're on a federal government site. Other ID Number (D4) Variations in trade, product, and company names affect search results. Report Date (F8) Visit the Product Code Builder Application and Tutorial for more information on building product codes. Classify Your Medical Device, Recalls, Market Withdrawals and Safety Alerts, How to Determine if Your Product is a Medical Device, Device Advice: Comprehensive Regulatory Assistance.

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