BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYTEC

    MDR report key: 2842804 · Received November 1, 2012

    Report

    Report Number
    2842804
    Event Type
    Malfunction
    Date Received
    November 1, 2012
    Date of Event
    September 14, 2012
    Report Date
    October 30, 2012
    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

    DURING COUNT NOTED A FLECK OF FOREIGN, SLIVER-LIKE DEBRIS WOVEN INTO RAYTEC. PACKAGE OF RAYTEC REMOVED FROM FIELD. ONLY NOTED ON SMALL AREA OF 1 OUT OF 10 RAYTEC; PACKAGED AND SENT TO NURSING INSTRUCTOR'S OFFICE FOR PRODUCT REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAYTEC GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE LWH SURGICOUNT MEDICAL UNK 7301

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR