BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M IOBAN 2 ANTIMICROBIAL INCISE DRAPE, 6651

    MDR report key: 2070231 · Received April 18, 2011

    Report

    Report Number
    2110898-2011-00043
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 4, 2011
    Manufacturer
    3M HEALTH CARE
    Product Code
    KKX
    PMA / PMN Number
    K0801550
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO OTHER ADVERSE PT EFFECTS WERE REPORTED. IF ADDITIONAL INFORMATION IS REC'D, A F/U REPORT WILL BE SUBMITTED. CONCLUSIONS: NO EVALUATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    3M REC'D INFORMATION FROM A CUSTOMER REGARDING A SKIN SLOUGH IN A RHEUMATOID PT. REPORTEDLY, A VERY SUPERFICIAL LAYER OF SKIN CAME OFF WITH THE 3M IOBAN 2 ANTIMICROBIAL INCISE DRAPE FOLLOWING A TOTAL KNEE REPLACEMENT PROCEDURE THAT WAS PREPPED WITH CHLORHEXIDINE. IT WAS ALSO NOTED THAT THE PT WAS TREATED WITH A NON-ADHERENT DRESSING AND HEALED OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M IOBAN 2 ANTIMICROBIAL INCISE DRAPE, 6651 878.4370 DRAPE, SURGICAL KKX 3M HEALTH CARE NA NK

    Patients

    Seq Age Sex Outcome Treatment
    1 NK Other