BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTEC XRAY DETECTABLE SPONGES

    MDR report key: 717558 · Received April 26, 2006

    Report

    Report Number
    MW1038903
    Event Type
    Malfunction
    Date Received
    April 26, 2006
    Date of Event
    April 1, 2006
    Report Date
    April 26, 2006
    Manufacturer
    KENDALL/TYCO
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    KENDALL X-RAY DETECTABLE SPONGES WERE OPENED TO THE STERILE OR FIELD; SPONGES CONTAMINATED WITH BROWNISH BLACK DRIED SUBSTANCE; NO ADVERSE EFFECT TO PT; CO NOTIFIED BY OR SUPERVISOR WITH INVESTIGATION ONGOING AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISTEC XRAY DETECTABLE SPONGES * GDY KENDALL/TYCO * 0100694393088037

    Patients

    Seq Age Sex Outcome Treatment
    1 *