BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROLOGICAL STEREOTAXIC INSTRUMENT

    MDR report key: 17527481 · Received August 12, 2023

    Report

    Report Number
    MW5134413
    Event Type
    Injury
    Date Received
    August 12, 2023
    Report Date
    February 11, 2020
    Manufacturer
    FHC, INC
    Product Code
    HAW
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LUMBAR CISTERN TUBE WAS DETACHED FROM THE INTERFACE JOINT. IT WAS ALSO INDICATED THAT THE TUBE WAS PULLED OUT, FOR FEAR OF AN INFECTION. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2234426 NEUROLOGICAL STEREOTAXIC INSTRUMENT NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW FHC, INC FC8001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown