FDA Adverse Event
Other
Summary report: N
NEURAGEN NERVE GUIDE 3MM ID X 3CM LEENGTH
MDR report key: 3844653
·
Received May 7, 2014
Report
- Report Number
- 1121308-2014-00015
- Event Type
- Other
- Date Received
- May 7, 2014
- Date of Event
- April 14, 2014
- Report Date
- April 16, 2014
- Manufacturer
- INTEGRA LIFESCIENCES CORP.
- Product Code
- JXI
- PMA / PMN Number
- K011168
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.
Description of Event or Problem · 1
IT WAS REPORTED EXPIRED NEURAGEN WAS IMPLANTED DURING NERVE REPAIR HAND SURGERY ON (B)(6) 2014. THERE WAS NO ADVERSE CONSEQUENCES TO THE PT REPORTED TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 276126 | NEURAGEN NERVE GUIDE 3MM ID X 3CM LEENGTH | NEURAGEN | JXI | INTEGRA LIFESCIENCES CORP. | 1115140 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |