BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUACEL AG BURN

    MDR report key: 3976141 · Received July 21, 2014

    Report

    Report Number
    1049092-2014-00332
    Event Type
    Injury
    Date Received
    July 21, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    FRO
    PMA / PMN Number
    K090254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. PLEASE NOTE: THREE (3) ISSUES ASSOCIATED WITH THIS PRODUCT; THEREFORE, A SEPARATE FDA FORM 3500A HAS BEEN GENERATED TO ADDRESS THE OTHER TWO (2) CASES REPORTED UNDER PATIENT IDENTIFIER# (3): (B)(6) AND (B)(6). REPORTED TO THE FDA ON JULY 18, 2014. THE ACTUAL DATE OF EVENT (B3) IS UNKNOWN, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S. COMPLAINT HANDLING AND CAPA PROCEDURES.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT EXPERIENCED PROLONGED BURNING TO THE WOUND BED ASSOCIATED WITH THE DRESSING AFTER IT'S APPLICATION. IT IS UNKNOWN WHETHER THE DRESSING WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425117 AQUACEL AG BURN DRESSING, WOUND, DRUG FRO CONVATEC INC. 403787 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention