BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUACEL AG-ANTIMICROBIAL AG HYDROFIBER DRESS

    MDR report key: 3915331 · Received May 28, 2014

    Report

    Report Number
    1000317571-2014-00030
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    CONVATEC LIMITED
    Product Code
    FRO
    PMA / PMN Number
    K0131814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. IT WAS FURTHER REPORTED VIA EMAIL ON (B)(4) 2014 THAT THE DRESSING WAS IMMEDIATELY PROHIBITED TO USE ON PTS. NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED UPON OPENING THE PRODUCT "THERE WERE DIRTY SPOTS AND LUMPED DRESSING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314493 AQUACEL AG-ANTIMICROBIAL AG HYDROFIBER DRESS DRESSING, WOUND, DRUG, 79FRO FRO CONVATEC LIMITED 403711 3E00133

    Patients

    Seq Age Sex Outcome Treatment
    1