BEUDAMED
    FDA Adverse Event Other Summary report: N

    3M LOBAN 2 ANTIMICROBIAL DRAPE

    MDR report key: 1001444 · Received February 14, 2008

    Report

    Report Number
    2110898-2008-00001
    Event Type
    Other
    Date Received
    February 14, 2008
    Date of Event
    February 9, 2008
    Report Date
    February 11, 2008
    Manufacturer
    3M HEALTH CARE
    Product Code
    KKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED, SO WE WERE UNABLE TO CONDUCT DEVICE EVALUATION. IT IS SPECIFIED IN "DIRECTION FOR USE" THAT SKIN OF ELDERLY PTS IS TYPICALLY FRAGILE AND THUS REQUIRES GREATER CARE WHEN REMOVING PRODUCTS. WE WERE UNABLE TO OBTAIN INFO FROM THE USER FACILITY IF THE INSTRUCTION WAS FOLLOWED WHEN REMOVING THIS PRODUCT.

    Description of Event or Problem · 1

    A 3MM RECEIVED INFO THAT A FEMALE EXPERIENCED FULL THICKNESS SKIN STRIPPING ON THE MEDIAL RIGHT THIGH, MEDIAL LEFT ANKLE, AND MEDIAL RIGHT ANKLE UPON REMOVAL OF THE DRAPE FOLLOWING AN AORTIC AND MITRAL VALVE REPLACEMENT AND TRANSESOPHAGEAL ECHOCARDIOGRAM IN 2007. REPORTED INITIALLY TREATED WITH SILVADENE, TELFA, AND KERLIX. EIGHT DAYS LATER, PLASTIC SURGEON INDICATED A 4X10 CM ESCHAR ALONG MEDIAL THIGH WITH SURROUNDING ERYTHEMA, A 3X5 CM NECROTIC ESCHAR ALONG MEDIAL MALLEOLUS OF LEFT ANKLE, AND A 1X2 CM ESCHAR ON MEDIAL MALLEOLUS OF RIGHT ANKLE. PLASTIC SURGEON INDICATED INJURIES CONSISTENT WITH FULL THICKNESS SKIN LOSS FROM SOME TYPE OF BURN. REPORTEDLY SKIN GRAFTING WAS DONE THE FOLLOWING MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M LOBAN 2 ANTIMICROBIAL DRAPE ANTIMICROBIAL INCISE SURGICAL DRAPE KKX 3M HEALTH CARE LOBAN 2 22X33 IN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| S