BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DERMACEA

    MDR report key: 11015570 · Received December 16, 2020

    Report

    Report Number
    3014527682-2020-00023
    Event Type
    Malfunction
    Date Received
    December 16, 2020
    Date of Event
    November 11, 2020
    Report Date
    December 15, 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 FIELD, AND A NEW PACK OF RAYTEC WAS OPENED. TRIED TO REMOVE AS MANY LOOSE THREADS AS POSSIBLE. THE GAUZE WAS CONTAINED IN ROI CPS, LLC CUSTOM PACK 880087014, LOT #: 82828N, GS00087N.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1484788 DERMACEA X-RAY SPONGE 4X4 16 PLY GDY COVIDIEN 441601 17061401, 17052003 10884527021239

    Patients

    Seq Age Sex Outcome Treatment
    1