BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRAPE,TAPE,ADHESVIE,4INX18IN

    MDR report key: 2991026 · Received March 6, 2013

    Report

    Report Number
    1423537-2013-00012
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    January 30, 2013
    Report Date
    March 6, 2013
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KGT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO LOT NUMBER WAS PROVIDED; WITHOUT THE LOT NUMBER WE ARE UNABLE TO REVIEW THE DEVICE HISTORY RECORD TO DETERMINE IF ANY DEVIATIONS TOOK PLACE DURING THE MANUFACTURE OF THIS DEVICE. NO SAMPLE WAS PROVIDED. WITHOUT THE ACTUAL SAMPLE, WE ARE UNABLE TO CONFIRM WHAT THE CUSTOMER EXPERIENCED, AND CANNOT DETERMINE A ROOT CAUSE FOR THE REPORTED ISSUE. WE WILL CONTINUE TO MONITOR FOR COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS PEELING OF SKIN (10CMX 10CM) ABOVE THE KNEE WHEN THE DRAPE TAPE WAS REMOVED AFTER SURGERY ON A (B)(6) MALE WITH A HIP FRACTURE. THE PREP WAS DONE WITH CHLOREXIDINE 2% AND ALCOHOL 70%. A DRESSING WITH BACTIGRAS AND COMPRESSES WERE APPLIED. THE PATIENT WAS DOING WELL OVERALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95512 DRAPE,TAPE,ADHESVIE,4INX18IN DRAPE, ADHESIVE, AEROSOL KGT CARDINAL HEALTH NO LOT GIVEN

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Other