BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETY SPONGE

    MDR report key: 2573500 · Received April 28, 2012

    Report

    Report Number
    2573500
    Event Type
    Malfunction
    Date Received
    April 28, 2012
    Date of Event
    April 18, 2012
    Report Date
    April 19, 2012
    Manufacturer
    SURGICOUNT MEDICAL
    Product Code
    GCY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SPONGES ARE LOOSELY WOVEN, X-RAY DETECTABLE STRIPS ARE LOOSELY WOVEN INTO SPONGE. A 4"X8" SPONGES SHREDDED WHILE THE SURGEON WAS USING THEM. THE X-RAY STRIP WAS NOT WOVEN TIGHTLY INTO THE GAUZE AND JUST FELL OUT. NAME: SURGICOUNT SAFETY SPONGE X-RAY DETECTABLE 4"X8" MASTER TAGGED DUAL, STRAIGHT X-RAY DETECTABLE STRIPS, DATA MATRIX TAGGED, 12-PLY. LOTS NOS: 8203, 7828, 7852, 7630, AND 8241.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFETY SPONGE GAUZE SPONGES X-RAY DETECTABLE (SEE B.5) GCY SURGICOUNT MEDICAL 8203

    Patients

    Seq Age Sex Outcome Treatment
    1