FDA Adverse Event
Malfunction
Summary report: N
REFLEXION
MDR report key: 22151171
·
Received June 5, 2025
Report
- Report Number
- MW5171114
- 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
- UNKNOWN
- Health Professional
- *
Narratives
Description of Event or Problem · 0
PATIENT WITH LUNG CANCER REPORTED A FEELING OF WARMTH DURING TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 602712 | REFLEXION | FLUDEOXYGLUCOSE F18-GUIDED RADIATION THERAPY SYSTEM | QVA | REFLEXION MEDICAL, INC. | RX1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |