BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYTEC SPONGE 18 X 18

    MDR report key: 2435969 · Received January 29, 2012

    Report

    Report Number
    2435969
    Event Type
    Malfunction
    Date Received
    January 29, 2012
    Date of Event
    November 30, 2011
    Report Date
    January 24, 2012
    Manufacturer
    SURGICOUNT MEDICAL
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAYTEC SPONGE 18 X 18 SPONGE - RAYTEC GDY SURGICOUNT MEDICAL * 7877

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR