BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUACEL AG SURGICAL COVER DRESSING

    MDR report key: 1882500 · Received October 21, 2010

    Report

    Report Number
    2243969-2010-00044
    Event Type
    Injury
    Date Received
    October 21, 2010
    Date of Event
    August 3, 2010
    Report Date
    September 24, 2010
    Manufacturer
    CONVATEC
    Product Code
    FRO
    PMA / PMN Number
    K091034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED TO THE FDA ON (B)(6), 2010. FDA REGISTRATION NUMBER: (B)(4).

    Description of Event or Problem · 1

    REPORTED BY THE COMPLAINANT AS FOLLOWS: PATIENT HAD A TOTAL KNEE ARTHROPLASTY ON (B)(6), 2010 AT (B)(4). AQUACEL AG SURGICAL WAS USED IN COMBINATION WITH AQUACEL AG POST OP AND BLISTERING WAS NOTED UNDER THE HYDROCOLLOID PORTION OF THE DRESSING ON (B)(6) 2010. THE AQUACEL AG SURGICAL DRESSING WAS DISCONTINUED AND THE BLISTERS WERE TREATED WITH TRIPLE ANTIBIOTIC OINTMENT. THE PATIENT WAS ALSO PLACED ON ORAL ANTIBIOTICS. THE BLISTERS HAVE SINCE HEALED; BUT SCARRING IS PRESENT. BETADINE PREP WAS USED IN SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention