BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETY-SPONGE; LAP SPONGE

    MDR report key: 1935289 · Received December 13, 2010

    Report

    Report Number
    1935289
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    November 2, 2010
    Report Date
    December 13, 2010
    Manufacturer
    SURGICOUNT MEDICAL
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE DOING SPONGE COUNTS WITH SURGICOUNT, A SPONGE WOULD NOT REGISTER ON COUNTER. UPON CLOSER EXAMINATION OF BAR CODE TAB, IT WAS DISCOVERED THE MIDDLE SECTION OF THE TAB WAS MISSING. SURGEON INFORMED OF MISSING PIECE OF BAR CODE (PAPER) AND NOT SURE IF BENEFICIAL. A X-RAY WAS DECIDED AT END OF THE PROCEDURE. BAR CODE PIECE OF PAPER LATER FOUND ON PLASTIC FLUID WARMER DRAPE. BOTH THE SPONGE AND AREA OF WARMER DRAPE BAGGED AND SENT TO SMDA (SAFE MEDICAL DEVICE ACT) STAFF FOR INVESTIGATION. NO X-RAY WAS DONE. NO HARM TO THE PATIENT IS KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFETY-SPONGE; LAP SPONGE SPONGE, GAUZE, X-RAY DETECTABLE GDY SURGICOUNT MEDICAL NA B6TF5U

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR