D
Patient 1
PT ADMITTED TO HOSPITAL WITH SWELLING AT INCISION SITE OF CRANIOTOMY THAT REQUIRED A SHUNT TO BE PLACED.
MAUDE MDR 407626
- MDR report key
- 407626
- Report number
- 75369-2002-00005
- Event key
- 0
- Event type
- 3
- Date of event
- 2002-07-02
- Date received
- 2002-07-22
- 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
- HOLLI KYLE
- Address
- 2555 MARCONI DRIVE, STE. 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 RTS 3CM | BALLOON CATHETER, RADIONUCLIDE APPLICATOR, MANUAL | PROXIMA THERAPEUTICS, INC. | KXK | 1030 | 1030 | 74084 | Y | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2002-07-22 | 0 | 1. H; 2. R |