BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSA SYS W/ADJ.DP.UNIT A.CONTROL RES.

    MDR report key: 7473822 · Received April 30, 2018

    Report

    Report Number
    3004721439-2018-00075
    Event Type
    Injury
    Date Received
    April 30, 2018
    Date of Event
    April 3, 2018
    Report Date
    September 6, 2019
    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

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018 MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING

    Additional Manufacturer Narrative · 0

    THE SHUNT SYSTEM WAS RETURNED IN THE RETURNKIT AND A BLOODY FLUID. REMAINS OF TISSUE WERE DETECTED. AS A RESULT, THE PROSA SHUNT SYSTEM WAS A HIGH RISK LEVEL AND COULD NOT BE TESTED. NO FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: (B)(6). IT WAS REPORTED THAT THE VALVE IS NOT ADJUSTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315368 PROSA SYS W/ADJ.DP.UNIT A.CONTROL RES. PRO SA JXG CHRISTOPH MIETHKE GMBH & CO. KG FV770T 20026780

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other| R