BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODERM

    MDR report key: 22747833 · Received August 8, 2025

    Report

    Report Number
    9618003-2025-02265
    Event Type
    Malfunction
    Date Received
    August 8, 2025
    Report Date
    July 10, 2025
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    NAD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D4: THE PART NUMBER / MODEL NUMBER AND LOT NUMBER INFORMATION FOR PRODUCT WAS UNFORTUNATELY UNKNOWN. THE ADVANCED WOUND CARE PERFORMANCE AND SAFETY SURVEYS ONLY STATED THAT DUODERM CGF DRESSING WAS USED. HOWEVER, IT IS UNCLEAR WHAT DUODERM CGF DRESSING WAS ACTUALLY RECEIVED. THEREFORE, THE NEAREST MODEL NUMBER 187660 HAS BEEN CAPTURED IN THE EMDR. E1: EVENT COUNTRY: ITALY. NAME OF AFFILIATION: (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. THIS COMPLAINT HAS BEEN EVALUATED. NO LOT NUMBER IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS EVALUATION WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: 1049092. MANUFACTURING SITE: 9618003.

    Description of Event or Problem · 0

    THE DISTRIBUTOR REPORTED THAT AS PER ADVANCED WOUND CARE PERFORMANCE AND SAFETY SURVEYS, THE COMPANY'S DRESSING WAS DIFFICULT TO REMOVE. THERE WAS NO HARM REPORTED AND NO PHOTO WAS AVAILABLE AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203470 DUODERM DRESSING,WOUND,OCCLUSIVE NAD CONVATEC DOMINICAN REPUBLIC INC 187660

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown