BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERMETIC PLUS EXTERNAL CSF DRAINAGE SYSTEM

    MDR report key: 568338 · Received January 18, 2005

    Report

    Report Number
    2648988-2005-00003
    Event Type
    Malfunction
    Date Received
    January 18, 2005
    Report Date
    January 18, 2005
    Manufacturer
    INTEGRA NEUROSCIENCES, INC.
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    REPORTED THAT THE PLASTIC OF THE EXTERNAL DRAINAGE SYSTEM WAS CRACKING AT THE LEVEL CROSS FROM THE BLACK KNOB. CUSTOMER ACKNOWLEDGED THAT ALTHOUGH THIS HAND OCCURRED NUMEROUS TIMES IN THE LAST COUPLE OF MONTHS, THIS WAS THE FIRST TIME THEY REPORTED IT. THERE HAS BEEN NO PT INJURY. THE CRACKED PLASTIC IS BEING SECURED BY TAPE, WHICH IS FRUSTRATING TO THE NURSING STAFF, BECAUSE THEY ARE CONSTANTLY CHECKING THE LEVEL AND FIDDLING WITH THE TAPE. THIS FACILITY HAS EXTERNAL DRAINAGE SYSTEM WITH LOT NUMBER 1041435 AND 1032445.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HERMETIC PLUS EXTERNAL CSF DRAINAGE SYSTEM EXTERNAL DRAINAGE SYSTEMS JXG INTEGRA NEUROSCIENCES, INC. * 1041435

    Patients

    Seq Age Sex Outcome Treatment
    1 *