BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPETZLER LUMBAR-PERITONEAL SHUNT KIT, 80CM CATH

    MDR report key: 2191551 · Received July 20, 2011

    Report

    Report Number
    2648988-2011-00029
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Report Date
    July 20, 2011
    Manufacturer
    INTEGRA, ANASCO
    Product Code
    JXG
    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 RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE PRODUCT WAS RECEIVED WITH THE BOTTOM OF THE OUTER PEEL PACK UNSEALED. THERE WAS NO PT CONTACT OR ANY PT INJURY. THERE WAS NO DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPETZLER LUMBAR-PERITONEAL SHUNT KIT, 80CM CATH NA JXG INTEGRA, ANASCO 1111073

    Patients

    Seq Age Sex Outcome Treatment
    1