MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-04-01 for STAR PROTON BEAM manufactured by .
[1881363]
Proton beam was not focused on tumor but inadvertently radiation was administered to normal brain tissue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5020144 |
| MDR Report Key | 2045800 |
| Date Received | 2011-04-01 |
| Date of Report | 2011-04-01 |
| Date of Event | 2011-02-25 |
| Date Added to Maude | 2011-04-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STAR PROTON BEAM |
| Generic Name | PROTON BEAM |
| Product Code | IWB |
| Date Received | 2011-04-01 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention; 3. Deathisabilit | 2011-04-01 |