BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSVII CATH 13CM W/O ANTI CHAMBER

    MDR report key: 2061509 · Received March 16, 2011

    Report

    Report Number
    9612007-2011-00012
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Report Date
    March 16, 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 INFORMATION.

    Description of Event or Problem · 1

    OSVII CATHETER 13CM WITHOUT THE ANTI CHAMBER, REPORTEDLY HAD A VALVE MECHANISM FAIL AND THE DRAINAGE STOPPED. THE VALVE WAS REPLACED. THE PRODUCT WAS IN CONTACT WITH THE PATIENT, BUT THERE WAS NO PATIENT INJURY. THE EVENT LED TO AN INCREASE THE SURGERY TIME (TIME TO REPLACE THE SHUNT), BUT THE AMOUNT OF TIME WAS NOT SPECIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSVII CATH 13CM W/O ANTI CHAMBER OSVII JXG INTEGRA, BIOT

    Patients

    Seq Age Sex Outcome Treatment
    1