N
Patient 1
MAUDE MDR 8155313
- MDR report key
- 8155313
- Report number
- 3003604053-2018-00193
- Event key
- 0
- Event type
- 3
- Date received
- 2018-12-12
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- JIM GONZALES
- Address
- 7000 WEST WILLIAM CANNON DRIVE AUSTIN TX 78735 US
- Phone
- 512-512-5123
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | LIGHT SOURCE, LED 3000 | CAMERA, TELEVISION, SURGICAL, WITH AUDIO | SMITH & NEPHEW, INC. | FWC | 72204011 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-12-12 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THE LIGHT SOURCE BOARD IS OUT; IT HAS NO LIGHT. NO PATIENT INJURY REPORTED.