BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIEW GUARD X RAY DETECTABLE

    MDR report key: 115031 · Received August 20, 1997

    Report

    Report Number
    MW1011934
    Event Type
    Malfunction
    Date Received
    August 20, 1997
    Date of Event
    June 18, 1997
    Report Date
    August 18, 1997
    Manufacturer
    TILLOTSON HEALTHCARE CO
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON INITIAL COUNT, THE PACKAGE OF VIEW GUARD X RAY DETECTABLE SURGICAL SPONGES HAD 11, RATHER THAN 10 SPONGES. THIS IS THE THIRD OCCURRENCE OF AN INCORRECT NUMBER OF SPONGES FROM TILLOTSON HEALTHCARE CORP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIEW GUARD X RAY DETECTABLE SURGICAL SPONGES GDY TILLOTSON HEALTHCARE CO PAR 324 PKG H17003

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO