BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POST CRANIOTOMY SUBDURAL ICP MONITORING S

    MDR report key: 512639 · Received January 20, 2004

    Report

    Report Number
    2023988-2004-00013
    Event Type
    Malfunction
    Date Received
    January 20, 2004
    Report Date
    January 19, 2004
    Manufacturer
    INTEGRA NEUROCARE LLC
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE MATERIALS MANAGER CALLED TO REPORT THE SUBDURAL CATHETER WOULD NOT ZERO. NO PATIENT INJURY WAS REPORTED. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POST CRANIOTOMY SUBDURAL ICP MONITORING S NEURO MONITORING GWM INTEGRA NEUROCARE LLC * W046013

    Patients

    Seq Age Sex Outcome Treatment
    1 *