BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSPONGE 4"X8" SPONGES

    MDR report key: 1408485 · Received April 27, 2009

    Report

    Report Number
    3005841380-2009-00001
    Event Type
    Malfunction
    Date Received
    April 27, 2009
    Date of Event
    April 1, 2009
    Report Date
    April 23, 2009
    Manufacturer
    CLEARCOUNT MEDICAL SOLUTIONS, INC.
    Product Code
    GDY
    PMA / PMN Number
    K073180
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER FACILITY DESCRIBED TO A CLEARCOUNT ASSOCIATE THAT A PORTION OF THE X-RAY THREAD FROM A CLEARCOUNT 4X8 GAUZE SPONGE WAS LOOSE AND BECAME DETACHED FROM THE SPONGE DURING USE. NO REPORT OF INJURY OR ADVERSE EVENT WAS MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTSPONGE 4"X8" SPONGES 4"X8" SURGICAL GAUZE GDY CLEARCOUNT MEDICAL SOLUTIONS, INC. 100317 - PACKAGE

    Patients

    Seq Age Sex Outcome Treatment
    1 CLEARCOUNT SMARTSPONGE PLUS SYSTEM