FDA Adverse Event
Summary report: N
MCLAREN PROTON THERAPY SYSTEM
MDR report key: 11076530
·
Received December 24, 2020
Report
- Report Number
- MW5098543
- Date Received
- December 24, 2020
- Report Date
- December 23, 2020
- Manufacturer
- MCLAREN HEALTH CARE
- Product Code
- LHN
- Report Source
- Voluntary report
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
THE MCLAREN PROTON THERAPY SYSTEM COLLIDED WITH THE DELIVERY NOZZLE WHEN THE PATIENT WAS BEING IMAGED ON THE COUCH. FDA SAFETY REPORT ID # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1534977 | MCLAREN PROTON THERAPY SYSTEM | SYSTEM, RADIATION THERAPY, CHARGED-PARTICLE, MEDICAL | LHN | MCLAREN HEALTH CARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |