BEUDAMED
    FDA Adverse Event Other Summary report: N

    DRAPE TOWEL, TIBURON

    MDR report key: 550341 · Received October 21, 2004

    Report

    Report Number
    1423507-2004-00101
    Event Type
    Other
    Date Received
    October 21, 2004
    Date of Event
    October 7, 2004
    Report Date
    October 21, 2004
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KKK
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USED SQUARE OFF TOWELS WITH ADHESIVE. WHEN REMOVED PT SKIN WAS TORN. PER O.R. TECH, UPON REMOVING DRAPE AFTER A LAP HYSTERECTOMY CASE SHE NOTICED LACERATIONS ON EACH SIDE OF PT'S THIGHS. TECH SUMMONED SURGEON AND THEY PERFORMED A QUICK ANALYSIS OF SITUATION. THE DRAPE WAS INSPECTED AND SKIN FOUND ADHERED TO DRAPE. THEY ALSO REVIEWED INSTRUCTIONS FOR THE 3M DURAPREP SOLUTION USED ON PT'S SKIN AS WELL. STAFF HAS BEEN INSTRUCTED TO FOLLOW RECOMMENDED USE OF PREP SOLUTION AND TO CAREFULLY REMOVE DRAPE AFTER EACH PROCEDURE. SURGEON ADMINISTERED APPROX TWO STITCHES TO EACH LACERATION. PER O.R. TECH SURGEON STATED PT IS DOING FINE POST OP AND NO OTHER MEDICAL INTERVENTIONS AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAPE TOWEL, TIBURON DRAPE TOWEL, TIBURON KKK CARDINAL HEALTH 7554 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other