BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARCOUNT SMARTSPONGE LAP SPONGES

    MDR report key: 2771601 · Received September 26, 2012

    Report

    Report Number
    MW5027104
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    September 21, 2012
    Report Date
    September 26, 2012
    Manufacturer
    MEDLINE INDUSTRIES
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON REMOVAL OF CLEAR COUNT SMART SPONGELAP SPONGE FROM OPEN CHEST IT WAS NOTED THAT THE SPONGE WAS FALLING APART SURGICAL TEAM REMOVED ALL VISIBLE PIECES AND WOUND WAS THEN IRRIGATED WITH VANCOMYCIN SOLUTION. THE MANUFACTURE OF PRODUCT WAS NOTIFIED AND THE SPONGES WERE TAKEN BY THE VENDOR FOR EVALUATION. THERE IS NO CURRENT RECALL OF THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARCOUNT SMARTSPONGE LAP SPONGES CLEARCOUNT SPONGES GDY MEDLINE INDUSTRIES HQ4505739137

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other