BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOPHYSA

    MDR report key: 6306639 · Received February 7, 2017

    Report

    Report Number
    3001587388-2017-17033
    Event Type
    Malfunction
    Date Received
    February 7, 2017
    Date of Event
    January 18, 2017
    Report Date
    February 6, 2017
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    PMA / PMN Number
    K013488
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    VALVE ADJUSTED ON ITS MEDIUM OPERATING PRESSURE BEFORE IMPLANTATION. THE USER STATES THAT HE OBSERVED A CHANGE OF THE OPERATING PRESSURE BEFORE IMPLANTATION OF THE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91236 SOPHYSA SOPHY ADJUSTABLE VALVE JXG SOPHYSA SM8 D0593

    Patients

    Seq Age Sex Outcome Treatment
    1 Other