BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROPROBE

    MDR report key: 20609491 · Received November 5, 2024

    Report

    Report Number
    20609491
    Event Type
    Malfunction
    Date Received
    November 5, 2024
    Date of Event
    August 29, 2024
    Report Date
    September 17, 2024
    Manufacturer
    ALPHA OMEGA ENGINEERING LTD.
    Product Code
    GZL
    UDI-DI
    07290014954946
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SUPPLY WAS TESTED BY SURGEON BEFORE USING IT ON PATIENT AND SUPPLY WAS FOUND TO BE "MANUFACTURED INCORRECTLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71358 NEUROPROBE ELECTRODE, DEPTH GZL ALPHA OMEGA ENGINEERING LTD. NEUROPROBE 87976 07290014954946

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown