BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    18 X 18 MASTER TAGGED LAP SPONGE

    MDR report key: 2199875 · Received August 1, 2011

    Report

    Report Number
    2199875
    Event Type
    Malfunction
    Date Received
    August 1, 2011
    Date of Event
    July 1, 2011
    Report Date
    August 1, 2011
    Manufacturer
    SURGICOUNT MEDICAL
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CIRCULATING RN OPENED A PACKAGE OF LAP SPONGES TO GIVE UP TO THE SCRUB PERSON AND UPON OPENING INNER WRAPPER NOTED SEVERAL (MORE THAN 2) BLACK SPECKS ON THE LAPS. SHE DID NOT PASS THE LAPS UP TO THE STERILE FIELD, AND REMOVED THEM FROM THE ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 18 X 18 MASTER TAGGED LAP SPONGE SPONGE, GAUZE GDY SURGICOUNT MEDICAL * 8009

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR