BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUACEL AG

    MDR report key: 1921961 · Received December 7, 2010

    Report

    Report Number
    2243969-2010-00058
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 10, 2010
    Manufacturer
    CONVATEC
    Product Code
    FRO
    PMA / PMN Number
    K013814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REPORTED BY THE COMPLAINANT AS FOLLOWS: UNABLE TO REMOVE ALL DRESSING FROM A DEEP CAVITY WOUND, NEED SURGERY TO REMOVE ALL AQUACEL DRESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUACEL AG ABSORBENT ANTIMICROBIAL WOUND DRESSING FRO CONVATEC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention