FDA Adverse Event
Malfunction
Summary report: N
ACCUDRAIN
MDR report key: 1780511
·
Received July 29, 2010
Report
- Report Number
- 1780511
- Event Type
- Malfunction
- Date Received
- July 29, 2010
- Date of Event
- July 22, 2010
- Report Date
- July 29, 2010
- Manufacturer
- INTEGRA NEUROSCIENCES PR
- Product Code
- JXG
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
Narratives
Description of Event or Problem · 1
ACCUDRAIN WAS LEAKING AT MANUFACTURER ANASTOMSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCUDRAIN | SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS | JXG | INTEGRA NEUROSCIENCES PR | INS-8400 | 1101621 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | NO OTHER THERAPIES |