BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGAV®

    MDR report key: 7161700 · Received January 3, 2018

    Report

    Report Number
    3004721439-2018-00002
    Event Type
    Injury
    Date Received
    January 3, 2018
    Report Date
    September 26, 2019
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO. KG
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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. ENTERED WITH LIMITIED INFORMATION. WILL FOLLOW UP WHEN INFORMATION IS PROVIDED.

    Additional Manufacturer Narrative · 0

    NO CLARIFICATION OF EVENT AVAILABLE; UNKNOWN TIME OF EVENT: 510K - K103003. (PATIENT CODE UPDATED; DEVICE CODE 3191 (NO CODE AVAILABLE) - MALFUNCTION UNSPECIFIEDMANUFACTURING EVALUATION: THE PRODUCT WAS NOT RETURNED AND THERE WAS NO SIGNED RELEASE FOR INVESTIGATION. EVALUATION OF DEVICE RECORDS SHOWED THERE WERE NO DEVIATIONS IN THE MANUFACTURING PROCESS, AND ALL CONTROLLED VALUES WERE WITHIN THE PERMISSIBLE TOLERANCES. THE SHUNT SYSTEM WAS STERILIZED BY MIETHKE AND RELEASED FOR SHIPMENT, AS DOCUMENTED.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: ENTERED WITH LIMITED INFORMATION. WILL FOLLOW UP WHEN INFORMATION IS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3928 PROGAV® PROGAV JXG CHRISTOPH MIETHKE GMBH & CO. KG FV432T 20033065

    Patients

    Seq Age Sex Outcome Treatment
    1 Other