BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUACEL AG-ANTIMICROBIAL HYDROFIBER DRESSING

    MDR report key: 3894300 · Received February 19, 2014

    Report

    Report Number
    1000317571-2014-00008
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Date of Event
    December 22, 2013
    Report Date
    January 22, 2014
    Manufacturer
    CONVATEC LIMITED
    Product Code
    FRO
    PMA / PMN Number
    K013814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PT BEING HARMED AS A RESULT OF THIS MALFUNCTION. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S COMPLAINT HANDLING AND CAPA PROCEDURES. NO ADD'L PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADD'L INFO BECOMES AVAILABLE, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    INFO RECEIVED VIA COMPLAINT FORM IS REPORTED AS FOLLOWS: "THE AQUACEL AG HAVE HAIR IN THE DRESSING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104749 AQUACEL AG-ANTIMICROBIAL HYDROFIBER DRESSING DRESSING, WOUND, DRUG FRO CONVATEC LIMITED 403711 1H02927

    Patients

    Seq Age Sex Outcome Treatment
    1