BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOPHYSA

    MDR report key: 6692266 · Received July 7, 2017

    Report

    Report Number
    3001587388-2017-17177
    Event Type
    Malfunction
    Date Received
    July 7, 2017
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    PMA / PMN Number
    K820312
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED RESERVOIR IS STILL IN ITS ORIGINAL PACKAGING, WITH BOTH INNER AND OUTER POUCHES STILL SEALED. THEREFORE, IT WAS NEVER USED. THE ANALYSIS SHOWS THAT THE INLET CONNECTOR IS BROKEN. IT IS DIFFICULT TO DETERMINE THE ORIGIN OF SUCH BREAK, BUT WE STRONGLY SUSPECT AN IMPROPER HANDLING OF THE DEVICE IN ITS PACKAGING.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURN TO US BY OUR DISTRIBUTOR WHEN HE NOTICED THAT THE INLET CONNECTOR WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474385 SOPHYSA RESERVOIR JXG SOPHYSA VR05 D0279

    Patients

    Seq Age Sex Outcome Treatment
    1 Other