D
Patient 1
IN 2003, PT COMPLAINED OF NEUROLOGICAL DECLINE. PT WAS PLACED ON STEROIDS AND IMPROVED GREATLY WITHIN 24 HOURS. CRANIOTOMY PERFORMED THE FOLLOWING MONTH. INITIAL FINDINGS WERE RADIATION NECROSIS WITH NO TUMOR OBSERVED.
MAUDE MDR 452317
- MDR report key
- 452317
- Report number
- 75369-2003-00001
- Event key
- 0
- Event type
- 3
- Date of event
- 2003-03-17
- Date received
- 2003-03-26
- 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 | BALLOON CATHETER, RADIONUCLIDE APPLICATOR MANUAL | PROXIMA THERAPEUTICS, INC. | KXK | NA | 1020 | 75297 | Y | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2003-03-26 | 0 | 1. H; 2. R |