BEUDAMED
    FDA Adverse Event Other Summary report: N

    3M LOBAN 2 ANTIMICROBIAL DRAPE

    MDR report key: 1121383 · Received August 13, 2008

    Report

    Report Number
    2110898-2008-00014
    Event Type
    Other
    Date Received
    August 13, 2008
    Date of Event
    June 23, 2005
    Report Date
    July 28, 2008
    Manufacturer
    3M HEALTH CARE
    Product Code
    KKX
    PMA / PMN Number
    K801550
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS BEING REPORTED FOLLOWING A REVIEW OF PREVIOUS CUSTOMER REPORTS OF SKIN STRIPPING. THIS EVENT WAS NOT INITIALLY REPORTED DUE TO THE LIMITED INFORMATION AVAILABLE FROM THE USER. THE INFORMATION REMAINS LIMITED, HOWEVER, A CONSERVATIVE APPROACH IS BEING TAKEN AND A REPORT FILED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN INCREASE IN TENSION BLISTERS. THE 3M QUESTIONNAIRE WAS SENT TO THE USER FACILITY BUT THE USER FACILITY DID NOT RESPOND. PHOTOS WERE PROVIDED. SOME OF THE PHOTOS WERE TAKEN AT VERY CLOSE RANGE AND LOCATION ON THE BODY, WERE NOT DISCERNABLE. SOME OF THE PHOTOS SHOW REDNESS WHICH APPEARS TO BE SKIN STRIPPING. SKIN STRIPPING COULD BE DUE TO FRAGILE SKIN OR TOO AGGRESSIVE REMOVAL OF THE DRAPE. IN SEVERAL OF THE PHOTOS, THERE IS EVIDENCE OF BRUISING INDICATING EITHER THE PATIENT HAD FRAGILE SKIN OR THE DRAPE WAS AGGRESSIVELY REMOVED OR THERE WAS SOME OTHER TRAUMA TO THE AREA. THERE IS NO TREATMENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M LOBAN 2 ANTIMICROBIAL DRAPE ANTIMICROBIAL SURGICAL DRAPE KKX 3M HEALTH CARE UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other