BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOPHYSA

    MDR report key: 15137293 · Received August 1, 2022

    Report

    Report Number
    3001587388-2022-22313
    Event Type
    Malfunction
    Date Received
    August 1, 2022
    Date of Event
    May 21, 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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CATHETER WAS IMPLANTED ON (B)(6) 2022. THE VALUES DISPLAYED WERE NORMAL AND COHERENT WITH THE PATIENT'S STATE. AFTER 2 DAYS, THE MONITOR SHOWED ERROR E001 WHICH LED TO CATHETER BEING EXPLANTED. SOME BENDS WERE REPORTEDLY SEEN ON THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2457407 SOPHYSA PSO-PT GWM SOPHYSA PSO-PBT

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male Other