BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIMBERLY-CLARK UNIVERSAL EXTREMITY DRAPE

    MDR report key: 1010547 · Received February 19, 2008

    Report

    Report Number
    1010547
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 19, 2008
    Manufacturer
    KIMBERLY-CLARK CORPORATION
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US

    Narratives

    Description of Event or Problem · 1

    WHEN NURSE WAS OPENING UNIVERSAL EXTREMITY DRAPE PACK, IT WAS DISCOVERED THAT THE STERILE OUTER COVER OF THE PACK HAD BEEN GLUED TO FENESTRATION IN THE DRAPE.====================== MANUFACTURER RESPONSE FOR SURGICAL DRAPE DISPOSABLE, KIMBERLY-CLARK UNIVERSAL EXTREMITY DRAPE======================WE HAVE PLACED A CALL TO THE MANUFACTURER'S SALE REPRESENTATIVE; WE ARE WAITING FOR A CALL BACK AS OF THIS WRITING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIMBERLY-CLARK UNIVERSAL EXTREMITY DRAPE EXTREMITY DRAPE KKX KIMBERLY-CLARK CORPORATION * AC7196B

    Patients

    Seq Age Sex Outcome Treatment
    1 *