BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICOUNT

    MDR report key: 2181531 · Received July 25, 2011

    Report

    Report Number
    2181531
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 25, 2011
    Manufacturer
    SURGICOUNT MEDICAL
    Product Code
    LWH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE SURGICAL PROCEDURE, A LAP SPONGE WAS REMOVED FROM THE PATIENT, BUT DID NOT CONTAIN THE ENTIRE DATA MATRIX TAG. THEREFORE, MISSING PARTS ARE NO WHERE TO BE FOUND AND SPONGE COULD NOT BE SCANNED OUT OF THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICOUNT LAPAROTOMY SPONGE 18X18 LWH SURGICOUNT MEDICAL * BCTSPW

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR OTHER