BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9618003-2021-01239

    MDR report key: 12171842 · Received July 15, 2021

    Report

    Report Number
    9618003-2021-01239
    Event Type
    Malfunction
    Date Received
    July 15, 2021
    Report Date
    June 16, 2021
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    FRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NAME: ACTUAL PRODUCT IS UNKNOWN. THE END USER COULD ONLY PROVIDE: AQUACEL (B)(4) SURGICAL BANDAGE (CONVATEC). THE PART NUMBER, LOT NUMBER, AND PRODUCT SIZE WAS NOT PROVIDED AND COULD NOT BE CONFIRMED. BRAND NAME: L3W0900: (B)(4), COMMON DEVICE NAME: DRESSING, WOUND, DRUG, PRODUCT CODE: FRO, 510(K) NUMBER: K091034. (B)(4). 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. (B)(4).

    Description of Event or Problem · 1

    THE END USER REPORTED THAT THE DRESSING WAS DIFFICULT TO REMOVE. THERE WAS NO HARM REPORTED. NO PHOTO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1075602 FRO CONVATEC DOMINICAN REPUBLIC INC

    Patients

    Seq Age Sex Outcome Treatment
    1