FDA Adverse Event
Malfunction
Summary report: N
LICOX BRAIN TISSUE OXYGEN MONITORING SYSTEM
MDR report key: 3220826
·
Received July 1, 2013
Report
- Report Number
- 3220826
- Event Type
- Malfunction
- Date Received
- July 1, 2013
- Date of Event
- July 1, 2013
- Report Date
- July 1, 2013
- Manufacturer
- INTEGRA LIFESCIENCES CORPORATION
- Product Code
- GWM
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- PA, US
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 299438 | LICOX BRAIN TISSUE OXYGEN MONITORING SYSTEM | DEVICE, MONITORING, INTRACRANIAL PRESSURE | GWM | INTEGRA LIFESCIENCES CORPORATION | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 YR |