BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEXION

    MDR report key: 22149925 · Received June 5, 2025

    Report

    Report Number
    MW5171095
    Event Type
    Malfunction
    Date Received
    June 5, 2025
    Report Date
    May 29, 2025
    Manufacturer
    REFLEXION MEDICAL, INC.
    Product Code
    QVA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THREE (3) PATIENTS WITH PROSTATE CANCER REPORTED A FEELING OF WARMTH DURING TREATMENT AND SEVERE SIDE EFFECTS INCLUDING URINARY FREQUENCY AND OTHER URINARY SYMPTOMS. REF REPORTS: MW5171096 AND MW5171097.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1401584 REFLEXION FLUDEOXYGLUCOSE F18-GUIDED RADIATION THERAPY SYSTEM QVA REFLEXION MEDICAL, INC. RX1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown