BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOPHYSA

    MDR report key: 15358749 · Received September 5, 2022

    Report

    Report Number
    3001587388-2022-22433
    Event Type
    Malfunction
    Date Received
    September 5, 2022
    Date of Event
    May 10, 2022
    Report Date
    May 9, 2022
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    PMA / PMN Number
    K141227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT WAS ADMITTED FOR HYDROCEPHALUS AND UNDERWENT VENTRICULOPERITONEAL SHUNT SURGERY. RE-EXAMINATION AFTER SURGERY REPORTEDLY REVEALED AN EDEMA AROUND THE SHUNT CATHETER. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269252 SOPHYSA BO19-10 JXG SOPHYSA BO19-10 136/1007F21011722/1005

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Other