BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP VYAFUSER KIT

    MDR report key: 25175779 · Received May 14, 2026

    Report

    Report Number
    MW5188268
    Event Type
    Malfunction
    Date Received
    May 14, 2026
    Report Date
    May 11, 2026
    Manufacturer
    PHILLIPS-MEDISIZE A/S
    Product Code
    FRN
    UDI-DI
    00000055273
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT'S WIFE REPORTS VYALEV PUMP STOPPED WORKING ABOUT 2 HOURS AGO. UNKNOWN IF DOSE WAS MISSED. UNKNOWN IF PATIENT EXPERIENCED AN ADVERSE EVENT. UNKNOWN IF DEFECTIVE RX IS AVAILABLE FOR RETURN. UNKNOWN IF DOCTOR IS AWARE. NO FURTHER INFO REPORTED. PARKINSON'S DISEASE. "(B)(4)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247394 PUMP VYAFUSER KIT PUMP, INFUSION FRN PHILLIPS-MEDISIZE A/S 00000055273

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male VYALEV SDV.