BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILLENNIUM HAND ACTIVATED MONOPOLAR FORCEP

    MDR report key: 19213049 · Received April 29, 2024

    Report

    Report Number
    MW5154436
    Event Type
    Malfunction
    Date Received
    April 29, 2024
    Date of Event
    March 18, 2024
    Report Date
    April 25, 2024
    Manufacturer
    AVALIGN TECHNOLOGIES, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT SUSTAINED MULTIPLE BURNS FROM MALFUNCTION OF INSULATED MONOPOLAR FORCEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131655 MILLENNIUM HAND ACTIVATED MONOPOLAR FORCEP ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI AVALIGN TECHNOLOGIES, INC. 72-551410C-PFGT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other