BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCANNER TAG

    MDR report key: 2152280 · Received July 2, 2011

    Report

    Report Number
    2152280
    Event Type
    Malfunction
    Date Received
    July 2, 2011
    Date of Event
    May 27, 2011
    Report Date
    July 2, 2011
    Manufacturer
    SURGICOUNT
    Product Code
    LWH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE SPONGE COUNTER SCANNER TAG ON ONE OF THE LAP SPONGES WAS NOTED TO BE RIPPING APART AND TORN AT THE END OF THE PROCEDURE. THE SCANNER WAS UNABLE TO READ THE TAG AND THEREFORE THE SPONGE COULD NOT BE SCANNED OUT OF THE CHART. A MANUAL COUNT WAS PERFORMED AND WAS NOTED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCANNER TAG SPONGE - LAP LWH SURGICOUNT * BBTTX1

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO