D
Patient 1
IMPLANTED 2003 AND BRACHYTHERAPY SUCCESSFULLY DELIVERED 18 DAYS LATER FOR 2 DAYS. ABOUT 6 MONTHS LATER PT PRESENTED WITH RADIATION NECROSIS DEEMED BY THE SITE PROBABLY TO BE RELATED TO THE DEVICE.
MAUDE MDR 560161
- MDR report key
- 560161
- Report number
- 1067103-2004-00024
- Event key
- 0
- Event type
- 3
- Date of event
- 2004-06-17
- Date received
- 2004-12-15
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- MARTINE SCHNEIDER
- Address
- 2555 MARCONI DRIVE SUITE 220 ALPHARETTA GA 30005 US
- Phone
- 770-770-7707
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | GLIASITE RADIATION THERAPY SYSTEM (RTS) | BALLOON CATHETER, RADIONUCLIDE APPLICATOR | PROXIMA THERAPEUTICS, INC. | KXK | * | 1030 | M20526 | Y | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2004-12-15 | 0 | 1. O |