BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSVII CATH.5CM, AVEC ANT

    MDR report key: 2102887 · Received May 4, 2011

    Report

    Report Number
    9612007-2011-00021
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Report Date
    May 4, 2011
    Manufacturer
    INTEGRA, BIOT
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    AN OSVII LUMBAR SHUNT CATHETER 5 CM WAS INSERTED. THE UNIT WAS FOUND TO BE BLOCKED AND WAS REPLACED BY A MEDTRONIC LUMBAR SHUNT. ADDITIONAL CLINICAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSVII CATH.5CM, AVEC ANT OSVII JXG INTEGRA, BIOT

    Patients

    Seq Age Sex Outcome Treatment
    1