BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODERM

    MDR report key: 22747836 · Received August 8, 2025

    Report

    Report Number
    9618003-2025-02264
    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 WOUNDCARE 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 HAS BEEN CAPTURED AS 187660. 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 ABILITY TO ABSORB EXUDATE WAS POOR FOR THE COMPANY¿S DRESSING. NO PHOTO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227148 DUODERM DRESSING,WOUND,OCCLUSIVE NAD CONVATEC DOMINICAN REPUBLIC INC 187660

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown