BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DERMACEA

    MDR report key: 10838716 · Received November 13, 2020

    Report

    Report Number
    3014527682-2020-00020
    Event Type
    Malfunction
    Date Received
    November 13, 2020
    Date of Event
    November 4, 2020
    Report Date
    November 13, 2020
    Manufacturer
    COVIDIEN
    Product Code
    GDY
    UDI-DI
    10884527021239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    RAYTEC GAUZE IS FRAYING AND LEAVING THREADS ON STERILE FIELD. THERE WAS PATIENT CONTACT. RAYTEC WAS REMOVED FROM THE FIELD AND NEW STERILE PACK OF RAYTEC WAS OPENED. TRIED TO REMOVE AS MANY LOOSE THREADS AS POSSIBLE. RAYTEC WAS CONTAINED WITHIN ROI CPS, LLC CUSTOM PROCEDURE KIT 880092020, OR00092T, LOT 83111T.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1305798 DERMACEA X-RAY 4X4 SPONGE 16PLY GDY COVIDIEN 441601 17063004 10884527021239

    Patients

    Seq Age Sex Outcome Treatment
    1