BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYTEC

    MDR report key: 2435968 · Received January 29, 2012

    Report

    Report Number
    2435968
    Event Type
    Malfunction
    Date Received
    January 29, 2012
    Date of Event
    December 12, 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

    Narratives

    Description of Event or Problem · 1

    LOOSE THREADS ON PKG OF RAYTEC. PACKAGE ISOLATED AND HANDED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAYTEC SPONGE - RAYTEC GDY SURGICOUNT MEDICAL N/A 8106

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR