BEUDAMED
    FDA Adverse Event Other Summary report: N

    3M LOBAN 2 ANTIMICROBIAL DRAPE

    MDR report key: 1121406 · Received August 13, 2008

    Report

    Report Number
    2110898-2008-00018
    Event Type
    Other
    Date Received
    August 13, 2008
    Date of Event
    October 4, 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 Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER APPROVED DRUG FACTS, WARNINGS FOR DURAPREP SURGICAL 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

    CUSTOMER REPORTED 2 PATIENTS, WHO WERE PREPPED WITH 3M DURAPREP SURGICAL SOLUTION FOR NEURO PROCEDURES, HAD SKIN STRIPPING UPON REMOVAL OF THE DRAPE. REPORTEDLY, THE DRAPE WAS REMOVED CAREFULLY, AND THERE WAS NOT TREATMENT.

    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 3M DURAPREP SURGICAL SOLUTION