BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP SPONGES, 18

    MDR report key: 2318047 · Received October 29, 2011

    Report

    Report Number
    2318047
    Event Type
    Malfunction
    Date Received
    October 29, 2011
    Date of Event
    October 13, 2011
    Report Date
    October 26, 2011
    Manufacturer
    SURGICOUNT MEDICAL
    Product Code
    LWH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON SETTING UP A CASE IT WAS NOTED THAT THE LAP SPONGE WAS SHREDDING. THE LAP SPONGE WAS REMOVED FROM SETUP AND IT WAS GIVEN TO THE SUPERVISOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP SPONGES, 18 SPONGE - LAP LWH SURGICOUNT MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR