BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUACEL DRS 2X45CM

    MDR report key: 5097568 · Received September 23, 2015

    Report

    Report Number
    1000317571-2015-30165
    Event Type
    Malfunction
    Date Received
    September 23, 2015
    Report Date
    February 27, 2014
    Manufacturer
    CONVATEC LIMITED
    Product Code
    NAC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF ACTIVITIES RELATED TO CONVATEC REMEDIATION PROTOCOL 2015-001-PRO AND PROTOCOL 2015-002-PRO. CONVATEC IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21CFR PART 803. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT WILL BE FILED ON A SUPPLEMENTAL REPORT (MEDWATCH 3500A).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "PRESUMED HUMAN HAIR FOUND IN THE WELLING OF THE PACKAGE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627622 AQUACEL DRS 2X45CM DRESSING,WOUND,HYDROPHILIC NAC CONVATEC LIMITED 177904 2A03466

    Patients

    Seq Age Sex Outcome Treatment
    1