BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A PLUS

    MDR report key: 11851962 · Received May 19, 2021

    Report

    Report Number
    3014527682-2021-00004
    Event Type
    Malfunction
    Date Received
    May 19, 2021
    Date of Event
    May 5, 2021
    Report Date
    May 19, 2021
    Manufacturer
    A PLUS INTERNATIONAL
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE GAUZE ITEM CONTAINED IN THIS REPORT IS MANUFACTURERED BY A PLUS INTERNATIONAL. ROI CPS, LLC RECEIVES THE GAUZE ITEM FROM THE MANUFACTURER AND PLACES THE ITEM INTO CONVENIENCE KITS.

    Description of Event or Problem · 1

    RAYTEC ARE FRAYING. RAYTEC REMOVED FROM FIELD. THERE WAS PATIENT CONTACT; HOWEVER, THERE WAS NO HARM TO PATIENT. NO DELAY TO CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749501 A PLUS GAUZE SPONGE XRAY 4X4IN 16PLY GDY A PLUS INTERNATIONAL 109505

    Patients

    Seq Age Sex Outcome Treatment
    1