BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VALVE

    MDR report key: 886932 · Received July 26, 2007

    Report

    Report Number
    9612007-2007-00034
    Event Type
    Injury
    Date Received
    July 26, 2007
    Report Date
    June 27, 2007
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    THE PATIENT'S WIFE CONTACTED INTEGRA LIFESCIENCES CORPORATION DIRECTLY, AND STATED THAT HER HUSBAND HAS HAD A HYDROCEPHALUS VALVE IMPLANTED. SHE ALLEGES THAT, THE VALVE MAY BE CAUSING A SERIOUS ALLERGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN VALVE CSF VALVE JXG INTEGRA NEUROSCIENCES IMPLANTS S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other