BEUDAMED
    FDA Adverse Event Other Summary report: N

    3M LOBAN 2 ANTIMICROBIAL DRAPE

    MDR report key: 1121384 · Received August 13, 2008

    Report

    Report Number
    2110898-2008-00016
    Event Type
    Other
    Date Received
    August 13, 2008
    Date of Event
    January 25, 2006
    Report Date
    July 28, 2008
    Manufacturer
    3M HEALTH CARE
    Product Code
    KKX
    PMA / PMN Number
    K801550
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    PER APPROVED, DRUG FACTS, WARNINGS FOR DURAPREP SOLUTION NOW STATE "TO AVOID SKIN INJURY, CARE SHOULD BE TAKEN WHEN REMOVING DRAPES, TAPES ETC ... APPLIED OVER [DURAPREP] FILM." 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

    3M CUSTOMER REPORTED 3 PATIENTS, ALL NEURO PROCEDURES PREPPED WITH DURAPREP SURGICAL SOLUTION, EXPERIENCED SKIN LOSS UPON REMOVAL OF THE DRAPE. REPORTEDLY, 2 PATIENTS WERE TREATED WITH BACITRACIN AND 1 WITH A TRANSPARENT DRESSING.

    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 33 YR Other 3M DURAPREP SURGICAL SOLUTION