BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLM INTRACRANIAL PRESSURE MONITORING KIT

    MDR report key: 1886049 · Received September 17, 2010

    Report

    Report Number
    2023988-2010-00032
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    May 23, 2010
    Report Date
    September 17, 2010
    Manufacturer
    INTEGRA NEUROSCIENCES SD
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN REC'D FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    VOLUNTARY MEDWATCH REPORT; MFR (B)(4) REC'D FROM FDA. AN (B)(4) OLM INTRACRANIAL MONITORING KIT; ERROR MESSAGE DISPLAYED STATING THAT THE MONITOR HAD BEEN DISCONNECTED. AS A RESULT OF THIS MALFUNCTION A NEW INTRA CRANIAL PRESSURE BOLT WAS PLACED. ADD'L INFO REC'D ON (B)(4) 2010 BY RISK MANAGER OF REPORTING FACILITY. THE CHILD DID NOT EXPERIENCED ANY NEGATIVE EFFECTS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLM INTRACRANIAL PRESSURE MONITORING KIT NA GWM INTEGRA NEUROSCIENCES SD 305000177099

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR