BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUACEL FOAM HYDROFIBER DRESSING, STERILE HE

    MDR report key: 5004080 · Received August 12, 2015

    Report

    Report Number
    1049092-2015-00466
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Report Date
    July 30, 2015
    Manufacturer
    CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C.
    Product Code
    NAC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    2

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. NO ADDITIONAL PATIENT/ EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. NOTE: THIS COMPLAINT INVOLVED FIVE (5) SEPARATE DRESSINGS. A SEPARATE FDA FORM 3500 A HAS BEEN COMPLETED FOR EACH DRESSING.

    Description of Event or Problem · 1

    IT WAS REPORTED FIVE (5) AQUACEL FOAM DRESSINGS WERE USED AS A PRIMARY DRESSING ON A GRADE II (LEFT) HEEL WOUND. AT THE TIME OF APPLICATION, THE WOUND ITSELF WAS NOT PAINFUL AND WAS FREE FROM ANY INFECTION. THE PATIENT'S SKIN WAS NOT CLAMMY AND NO EMOLLIENTS HAD BEEN USED. OVER OA ONE WEEK PERIOD, THE NURSE HAD TO CHANGE THE DRESSING FREQUENTLY DUE TO NONADHERENCE OF THE DRESSING TO THE WOUND. THE DRESSING WAS DISCONTINUED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529233 AQUACEL FOAM HYDROFIBER DRESSING, STERILE HE DRESSING, WOUND, HYDROPHILIC NAC CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C. 420625

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR