BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUDENZ VALVE

    MDR report key: 438767 · Received January 16, 2003

    Report

    Report Number
    2648988-2003-00001
    Event Type
    Malfunction
    Date Received
    January 16, 2003
    Report Date
    January 16, 2003
    Manufacturer
    HEYER SCHULTE NEUROCARE INC
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER CHECKING THE VALVE BEFORE THE OPERATION, THE DR FILLED THE SALINE INTO THE VALVE AND VENTRICULAR CATHETER, CONNECTED THEM AND IMPLANTED THEM. THE PHYSICIAN THEN INSERTED THE PERITONEAL CATHETER UNDER THE SKIN AND CONNECTED THE PERITONEAL CATHETER TO THE VALVE, HOWEVER HE FOUND BAD REPULSION OF THE PUSHED VALVE FOR PUMPING AND DECIDED TO REMOVE THE VALVE TOGETHER WITH THE VENTRICULAR VALVE AND PERITONEAL VALVE. THE PHYSICIAN IMPLANTED ANOTHER NEW VALVE (NL850-1330) WHICH WAS KEPT IN THE HOSP TOGETHER WITH THE NL850-1228 AND THE NL850-1380. AFTER COMPLETION OF THE OPERATION, HE PUSHED THE RESERVOIR OF THE REMOVED VALVE WHILE THE PERITONEAL CONNECTOR WAS CLOSED BY PUSHING BY FINGERS AND THEN UNTOUCHING HIS FINGERS FROM THE RESERVOIR. EVENTUALLY THE PHYSICIAN CONFIRMED THAT THE REMOVED VALVE COULD NOT RETURN TO THE SHAPE BEFORE PUSHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUDENZ VALVE CSF PRODUCT JXG HEYER SCHULTE NEUROCARE INC * 1020652

    Patients

    Seq Age Sex Outcome Treatment
    1 *