BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA VS KIR, NEONATE SIZE WITH RICKHAM RESERVOIR

    MDR report key: 1660965 · Received April 12, 2010

    Report

    Report Number
    2648988-2010-00025
    Event Type
    Malfunction
    Date Received
    April 12, 2010
    Report Date
    April 13, 2010
    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

    AN ULTRA VS KIT, NEONATE SIZE WITH RICKHAM RESERVOIR, MED. PRESSURE WAS FOUND TO BE OCCLUDED WHEN IMPLANTED DURING AN OPERATION. THE PATENCY TEST WAS NOT PERFORMED PRIOR TO IT BEING IMPLANTED. ANOTHER ULTRA VS KIT WAS USED. AN UNSPECIFIED INJURY WAS REPORTED. A TEST OF INITIAL DEVICE REVEALED THAT THE FLOW WAS "RETARDED." ADD'L CLINICAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA VS KIR, NEONATE SIZE WITH RICKHAM RESERVOIR NA JXG

    Patients

    Seq Age Sex Outcome Treatment
    1