BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITREQ

    MDR report key: 16143329 · Received January 11, 2023

    Report

    Report Number
    3012037425-2023-00002
    Event Type
    Malfunction
    Date Received
    January 11, 2023
    Date of Event
    December 12, 2022
    Report Date
    January 11, 2023
    Manufacturer
    VITREQ BV
    Product Code
    JOS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    POST-SURGERY THE CT00.D01 - VITREQ, CRYO TREQ PROBE BX/3 DEVICE CAME APART AND THE DR. WAS HIT BY A PLASTIC PART IN THE ARM. NE MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1471341 VITREQ CRYOTREQ JOS VITREQ BV 20229138

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown