BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIMITORR VOLUME EVD 20ML

    MDR report key: 1660214 · Received April 14, 2010

    Report

    Report Number
    2648988-2010-00024
    Event Type
    Other
    Date Received
    April 14, 2010
    Report Date
    April 14, 2010
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    REPORTING FACILITY BELIEVED THE THREE WAY STOP COCK BETWEEN BURETTE AND THE COLLECTION BAG MAY HAVE BEEN POSITIONED INCORRECTLY RESULTING IN OVERDRAINAGE OF CEREBRAL SPINAL FLUID. NO PT INJURY OCCURRED AS A RESULT OF THE EVENT. ADDITIONAL CLINICAL INFO REQUESTED FROM THE REPORTING FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIMITORR VOLUME EVD 20ML NA JXG INTEGRA NEUROSCIENCES PR 1095546 ETC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other