BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUACEL AG WSF 2X45CM

    MDR report key: 5111558 · Received September 29, 2015

    Report

    Report Number
    1000317571-2015-30034
    Event Type
    Malfunction
    Date Received
    September 29, 2015
    Report Date
    February 27, 2014
    Manufacturer
    CONVATEC LIMITED
    Product Code
    FRO
    PMA / PMN Number
    K080383
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF ACTIVITIES RELATED TO CONVATEC REMEDIATION PROTOCOL (B)(4). 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). EVALUATION CONCLUSIONS ARE REFLECTED IN THE CODES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "TWO PADS WERE SEALED PART IN AND PART OUT OF PACKAGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641409 AQUACEL AG WSF 2X45CM DRESSING, WOUND, DRUG FRO CONVATEC LIMITED 403771 2C00596

    Patients

    Seq Age Sex Outcome Treatment
    1