BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOPHYSA

    MDR report key: 15137284 · Received August 1, 2022

    Report

    Report Number
    3001587388-2022-22311
    Event Type
    Malfunction
    Date Received
    August 1, 2022
    Date of Event
    June 3, 2022
    Report Date
    August 1, 2022
    Manufacturer
    SOPHYSA
    Product Code
    GWM
    PMA / PMN Number
    K162108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE SURGEON IMPLANTED THE CATHETER ON (B)(6) 2022, AND THE VALUE SHOWED NORMAL IN THE NEXT SEVEN DAYS.ON (B)(6) 2022, THE SURGEON FOUND THAT THE VALUE JUMPED BETWEEN 6-38MMHG. THE USER THOUGHT THE MONITORING VALUE WAS INACCURATE AND REPORTED THE CATHETER AS AN ADVERSE EVENT. THIS CATHETER HAS BEEN DISCARDED BY THE HOSPITAL. NO HEALTH CONSEQUENCES WERE REPORTED TO HAVE HAPPEND ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2457398 SOPHYSA PSO-PBT GWM SOPHYSA PSO-PBT

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other