BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M IOBAN 2 ANTIMICROBIAL INCISE DRAPE

    MDR report key: 2140395 · Received June 16, 2011

    Report

    Report Number
    2110898-2011-00084
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 18, 2011
    Manufacturer
    3M HEALTH CARE
    Product Code
    KKX
    PMA / PMN Number
    K801550
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO WAS NOT AVAILABLE. NO OTHER ADVERSE PT EFFECTS WERE REPORTED. IF ADDITIONAL INFO IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. NO EVAL WILL BE PERFORMED.

    Description of Event or Problem · 1

    3M RECEIVED INFO FROM A CUSTOMER REPORTING THAT 12 TO 15 PTS IN THE LAST 4-5 MONTHS, (B)(6) AND OLDER, EXPERIENCED SKIN PULLING OFF WITH THE DRAPE FOLLOWING MOSTLY TOTAL KNEE REPLACEMENT PROCEDURES AND SOME TOTAL HIP REPLACEMENT PROCEDURES. SOME OF THE PTS (NUMBER UNK) WERE TREATED WITH SILVADENE. REPORTEDLY, SKIN WAS REMOVED FROM THE MEDIAL/LATERAL EDGES OF THE KNEE, OR ABOVE THE INCISION, OR BELOW THE INCISION. REPORTEDLY, THE SKIN WAS PREPPED WITH A DOUBLE APPLICATION OF DURAPREP UNTIL THE ISSUE BEGAN. ONCE SKIN REMOVAL WAS OBSERVED, THE HOSPITAL STAFF PREPPED WITH SINGLE APPLICATIONS OF DURAPREP THEN CHLOROPREP WHICH HELPED SOME. FINALLY, SINGLE APPLICATIONS OF CHLOROPREP THEN DURAPREP, BUT THERE WERE STILL ONE TO TWO CASES OF SKIN REMOVAL. IT WAS REPORTED THAT THE DRAPE WAS BEING APPLIED WITH THE KNEE IN FLEXION, THE SKIN PREP IS DRY, AND THEY ARE CAREFUL NOT TO STRETCH THE DRAPE DURING APPLICATION. THE HOSPITAL STAFF NOTED THAT THEY REMOVE THE DRAPE VERY GENTLY AND FOLD IT BACK ON ITSELF. THE SCRUB TECH NOTED THAT THIS DRAPE CAME FROM A KIT AND THAT THE KITS ARE GAMMA STERILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M IOBAN 2 ANTIMICROBIAL INCISE DRAPE 878.4370 DRAPE, SURGICCAL KKX 3M HEALTH CARE NA 2012-11 RF

    Patients

    Seq Age Sex Outcome Treatment
    1 NK Required Intervention