BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGAV 2.0 SHUNTSYSTEM MIT SPRUNG RESERVOIR

    MDR report key: 7249401 · Received February 7, 2018

    Report

    Report Number
    3004721439-2018-00014
    Event Type
    Malfunction
    Date Received
    February 7, 2018
    Date of Event
    January 19, 2018
    Report Date
    February 7, 2018
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO. KG
    Product Code
    JXG
    PMA / PMN Number
    K141687
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF CHRISTOPH MIETHKE GMBH & CO. KG (MANUFACTURER). EXEMPTION NUMBER: E2017044. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 0

    (B)(6). IT WAS REPORTED THAT THE STAIN ON THE VALVE, NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93635 PROGAV 2.0 SHUNTSYSTEM MIT SPRUNG RESERVOIR PROGAV JXG CHRISTOPH MIETHKE GMBH & CO. KG FX441T 20031565

    Patients

    Seq Age Sex Outcome Treatment
    1 Other