BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSA VALVE

    MDR report key: 9668049 · Received February 4, 2020

    Report

    Report Number
    3004721439-2020-00035
    Event Type
    Injury
    Date Received
    February 4, 2020
    Date of Event
    January 16, 2020
    Report Date
    February 4, 2020
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO. KG
    Product Code
    JXG
    PMA / PMN Number
    K141687
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    HEIGHT: 175CM. NO TESTS HAVE BEEN PERFORMED. THE VALVE WAS SENT TO US DRY (I.E. NOT SUBMERSED IN LIQUID AS RECOMMENDED). AN INVESTIGATION OF VALVES SENT IN DRY IS NOT MEANINGFUL, AS THE PRODUCT CHARACTERISTICS CAN BE INFLUENCED BY DRY RESIDUES OF CEREBROSPINAL FLUID OR BLOOD AND THEREFORE CANNOT BE EVALUATED BY US. WE ASK FOR YOUR UNDERSTANDING THAT WE DO NOT PERFORM TESTS ON PRODUCTS SENT IN THIS WAY. IN OUR VIEW, THERE IS NO FURTHER NEED FOR REGULATORY ACTION. WE CAN EXCLUDE A DEFECT AT THE TIME OF RELEASE. THE VALVE MET ALL SPECIFICATIONS OF THE FINAL INSPECTION WHEN RELEASED FROM CHRISTOPH MIETHKE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VALVE IS NOT ADJUSTABLE. THE REPORTER INDICATED THAT A 2 MONTH 1 DAY POST-OPERATIVE VALVE IS NOT ADJUSTABLE AND REQUIRED EXPLANTATION. ADDITIONAL EVENT DETAILS WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126776 PROSA VALVE HYDROCEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO. KG FV701T 20044238

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention