BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A PLUS

    MDR report key: 12080597 · Received June 28, 2021

    Report

    Report Number
    3014527682-2021-00011
    Event Type
    Malfunction
    Date Received
    June 28, 2021
    Date of Event
    June 14, 2021
    Report Date
    June 28, 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

    ROI CPS, LLC RETURNED ALL ON-HAND STOCK OF GZ-4416-9S, LOT 109505 TO THE VENDOR A PLUS INTERNATIONAL ON 5/27/2021 DUE TO CUSTOMER COMPLAINTS FOR OTHER DEFECTS PRIOR TO RECEIVING THE COMPLAINT FOR THE GAUZE FRAYING.

    Description of Event or Problem · 1

    FRAYING RAYTEC IN CUSTOM PACK. NO PATIENT CONTACT. DISCOVERED DURING SET-UP. RAYTEC REMOVED FROM FIELD. NO HARM TO PATIENT AND NOT DELAY TO CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    978120 A PLUS GAUZE SPONGE XRAY 4X4IN 16PLY GDY A PLUS INTERNATIONAL 109505

    Patients

    Seq Age Sex Outcome Treatment
    1