BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSA SHUNTSYSTEM MIT PROGAV 2.0

    MDR report key: 7765174 · Received August 8, 2018

    Report

    Report Number
    3004721439-2018-00166
    Event Type
    Injury
    Date Received
    August 8, 2018
    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
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF CHRISTOPH MIETHKE GMBH & CO. KG (MANUFACTURER, REGISTRATION NO. 3004721439). EXEMPTION NUMBER: E2017044. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: (B)(6). IT WAS REPORTED THAT THERE WAS BLOCKAGE IN THE HYDROCEPHALUS SHUNT VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602203 PROSA SHUNTSYSTEM MIT PROGAV 2.0 HYDROCEPHALUS SHUNT JXG CHRISTOPH MIETHKE GMBH & CO. KG FX996T 20036968

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention