BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUACEL AG DRS 2X45CM

    MDR report key: 5113254 · Received September 30, 2015

    Report

    Report Number
    1000317571-2015-30253
    Event Type
    Malfunction
    Date Received
    September 30, 2015
    Date of Event
    February 19, 2014
    Report Date
    February 27, 2014
    Manufacturer
    CONVATEC LIMITED
    Product Code
    FRO
    PMA / PMN Number
    K063271
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 PART OF THE PRODUCT (RIBBON) HAS GOTTEN STUCK IN THE PACKAGING. THE PRODUCT WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645702 AQUACEL AG DRS 2X45CM DRESSING, WOUND, DRUG FRO CONVATEC LIMITED 403712 3J00171

    Patients

    Seq Age Sex Outcome Treatment
    1