BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPAROTOMY DRAPE

    MDR report key: 1945062 · Received December 19, 2010

    Report

    Report Number
    1945062
    Event Type
    Malfunction
    Date Received
    December 19, 2010
    Date of Event
    November 8, 2010
    Report Date
    December 19, 2010
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LAPAROTOMY DRAPE IN NEUROSURGERY LAMINECTOMY CUSTOM PACKS SEPARATES AT THE SEAM BETWEEN THE HORIZONTAL AND VERTICAL PIECES. THE SEPARATION THEN LEAVES UNSTERILE AREA EXPOSED IN THE MIDDLE OF THE STERILE FIELD. THE EXPOSED ARE MUST THEN BE COVERED WITH ANOTHER DRAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAPAROTOMY DRAPE LAPAROTOMY DRAPE KKX CARDINAL HEALTH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR