FDA Adverse Event
Other
Summary report: N
NEURAGEN NERVE GUIDE 4MM ID X 2CM LENGTH
MDR report key: 1912778
·
Received November 3, 2010
Report
- Report Number
- 1121308-2010-00023
- Event Type
- Other
- Date Received
- November 3, 2010
- Date of Event
- October 25, 2010
- Report Date
- November 3, 2010
- Manufacturer
- INTEGRA LIFESCIENCES CORP
- Product Code
- JXI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.
Description of Event or Problem · 1
THE REPORTER STATED THAT NEURAGEN WITH A LABEL EXPIRATION DATE OF SEPTEMBER 30, 2010 WAS IMPLANTED DURING A SURGICAL PROCEDURE ON (B)(6) 2010. THE PRODUCT HAD 13 MONTHS REMAINING SHELF LIFE WHEN RECEIVED AT THE USER FACILITY FROM THE MANUFACTURER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEURAGEN NERVE GUIDE 4MM ID X 2CM LENGTH | NEURAGEN | JXI | INTEGRA LIFESCIENCES CORP | 1083556 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NOT PROVIDED |