BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUACEL FOAM

    MDR report key: 3937305 · Received June 25, 2014

    Report

    Report Number
    1049092-2014-00235
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    CONVATEC, INC.
    Product Code
    FRO
    PMA / PMN Number
    K123481
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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. THIRD PARTY MANUFACTURER: (B)(4). NOTE: THE ACTUAL DATE OF EVENT 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 AN ISSUE WITH A SKIN REACTION AROUND THE ADHESIVE BORDER OF THE AQUACEL FOAM ADHESIVE DRESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371288 AQUACEL FOAM DRESSING, WOUND, DRUG FRO CONVATEC, INC. 420804 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention