BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUACEL AG - ANTIMICROBIAL AG HYDROFIBER DRESS

    MDR report key: 3994351 · Received July 23, 2014

    Report

    Report Number
    1000317571-2014-00051
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    CONVATEC LIMITED
    Product Code
    FRO
    PMA / PMN Number
    K013814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED "WIDTH OF AN END IS ABOUT 5MM (1 PIECE) AND THE END WAS WELDED IN THE SEAM OF THE INDIVIDUAL PACKAGE (2 PIECES)". NOTE: ISSUE OCCURRED ON (2) SEPARATE CASES. A SEPARATE 3500A FORM HAS BEEN COMPLETED FOR THE OTHER (1) CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432227 AQUACEL AG - ANTIMICROBIAL AG HYDROFIBER DRESS DRESSING, WOUND, DRUG FRO CONVATEC LIMITED 403712 3J00171

    Patients

    Seq Age Sex Outcome Treatment
    1