BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POST CRANIOTOMY SUBDURAL

    MDR report key: 538540 · Received March 25, 2004

    Report

    Report Number
    2023988-2004-00029
    Event Type
    Malfunction
    Date Received
    March 25, 2004
    Report Date
    March 25, 2004
    Manufacturer
    INTEGRA NEUROCARE LLC
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THAT THE DEVICE WAS IN THE PT'S CRANIUM BUT THE INTRACRANIAL PRESSURE READING WAS UNSTABLE BETWEEN +60 TO 0 MMHG. NO PT INJURY WAS REPORTED. ADDITIONAL INFO WAS REQUESTED IN MARCH 2004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POST CRANIOTOMY SUBDURAL NEURO MONITORING GWM INTEGRA NEUROCARE LLC * W049503

    Patients

    Seq Age Sex Outcome Treatment
    1 *