BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGAV SUNTSYSTEM

    MDR report key: 7635968 · Received June 25, 2018

    Report

    Report Number
    3004721439-2018-00108
    Event Type
    Malfunction
    Date Received
    June 25, 2018
    Date of Event
    May 28, 2018
    Report Date
    June 25, 2018
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO. KG
    Product Code
    JXG
    PMA / PMN Number
    K103003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: (B)(6). IT WAS REPORTED THAT THE DEVICE MALFUNCTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477197 PROGAV SUNTSYSTEM PRO GAV JXG CHRISTOPH MIETHKE GMBH & CO. KG FV434T 20027983

    Patients

    Seq Age Sex Outcome Treatment
    1 Other