FDA Adverse Event
Summary report: N
MCLAREN PROTON THERAPY SYSTEM
MDR report key: 11201305
·
Received January 19, 2021
Report
- Report Number
- MW5098882
- Date Received
- January 19, 2021
- Report Date
- January 14, 2021
- 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 ROTATED UNCONTROLLABLY AND COLLIDED WITH THE NOZZLE OF THE DELIVERY SYSTEM. FDA SAFETY REPORT ID # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 95442 | MCLAREN PROTON THERAPY SYSTEM | SYSTEM, RADIATION THERAPY, CHARGED-PARTICLE, MEDICAL | LHN | MCLAREN HEALTH CARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |