BEUDAMED
    FDA Adverse Event Other Summary report: N

    3M LOBAN 2 ANTIMICROBIAL DRAPE

    MDR report key: 1121404 · Received August 13, 2008

    Report

    Report Number
    2110898-2008-00020
    Event Type
    Other
    Date Received
    August 13, 2008
    Date of Event
    May 21, 2004
    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
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS SPECIFIED IN THE "DIRECTIONS FOR USE" THAT SKIN OF ELDERLY PATIENTS IS TYPICALLY FRAGILE AND THUS REQUIRES GREATER CARE WHEN REMOVING THE DRAPE. WE WERE UNABLE TO OBTAIN INFORMATION FROM THE USER FACILITY IF INSTRUCTIONS WERE FOLLOWED PROPERLY WHEN APPLYING/ REMOVING THE LOBAN DRAPE. 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 ELDERLY PATIENT EXPERIENCED SKIN STRIPPING OF BLISTERED AREAS WHEN THE LOBAN DRAPE WAS REMOVED. THE CUSTOMER SAID THEY APPLIED THE DRAPE WITH A LITTLE TENSION. CUSTOMER WAS NOT AWARE OF ANY 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 LOBAN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other