BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUDENZ PERITONEAL LOW PRESSURE CATHETER

    MDR report key: 385607 · Received March 28, 2002

    Report

    Report Number
    2648988-2002-00004
    Event Type
    Malfunction
    Date Received
    March 28, 2002
    Report Date
    March 28, 2002
    Manufacturer
    HEYER-SCHULTE NEUROCARE INC.
    Product Code
    GBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ONE SAMPLE WILL BE RETURNED WHICH WAS USED BY A PATIENT WITH NO INFECTIOUS DISEASE. THE PHYSICIAN REMOVED THE CATHETER FROM THE PATIENT AND IMPLANTED A NEW CATHETER. THE BROKEN PART WAS FOUND TO EXIST ON THE REMOVED CATHETER. IT IS UNKNOWN IF PATIENT INJURY OCCURRED BUT INTERVENTION WAS REQUIRED, CATHETER WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUDENZ PERITONEAL LOW PRESSURE CATHETER CSF CATHETER GBW HEYER-SCHULTE NEUROCARE INC. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention