FDA Adverse Event
Other
Summary report: N
NEURAGEN NERVE GUIDE 5MM ID X 2CM LENGTH
MDR report key: 1576597
·
Received January 11, 2010
Report
- Report Number
- 1121308-2010-00002
- Event Type
- Other
- Date Received
- January 11, 2010
- Date of Event
- December 21, 2009
- Report Date
- January 8, 2010
- Manufacturer
- INTEGRA LIFESCIENCES CORP.
- Product Code
- JXI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.
Description of Event or Problem · 1
THE REPORTER STATED THAT THE PRODUCT WHICH HAD AN EXPIRATION DATE OF 06/31/2009 WAS IMPLANTED DURING A LEFT WRIST ARTHROTOMY PROCEDURE ON (B)(6) 2009. THERE HAS BEEN NO ADVERSE OUTCOME FOR THE PATIENT TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEURAGEN NERVE GUIDE 5MM ID X 2CM LENGTH | NEURAGEN | JXI | INTEGRA LIFESCIENCES CORP. | 1071612 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |