D
Patient 1
DURING SIX MONTH FOLLOW-UP FOR INTRA-OPERATIVE RADIATION TREATMENT OF THE BREAST, THE MAMMOGRAM SHOWED POWDERY MATERIAL ON AND NEAR THE TREATMENT SITE. INCIDENT DID NOT RESULT IN A PATIENT INJURY.
MAUDE MDR 2158590
- MDR report key
- 2158590
- Report number
- 3005594788-2011-00022
- Event key
- 0
- Event type
- 3
- Date of event
- 2011-04-27
- Date received
- 2011-06-06
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- STEVE LIN
- Address
- 345 POTRERO AVE SUNNYVALE CA 94085 US
- Phone
- 408-408-4084
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | AXXENT FLEXISHIELD MINI | BEAM BLOCKS FOR RADIATION THERAPY | XOFT, INC. | IXI | F5300 | F5300 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2011-06-06 | 0 |
Event Narratives#
N
Patient 1
DURING SIX MONTH FOLLOW-UP FOR INTRA-OPERATIVE RADIATION TREATMENT OF THE BREAST, THE MAMMOGRAM SHOWED POWDERY MATERIAL ON AND NEAR THE TREATMENT SITE. DEVICE HAS NOT BEEN RETURNED. INCIDENT DID NOT RESULT IN A PATIENT INJURY. COMPANY IS COLLECTING FURTHER INFORMATION TO ASCERTAIN THIS EVENT. THIS MDR IS RELATED TO MDR 3005594788-2011-00001.