FDA Adverse Event
Other
Summary report: N
NEURAGEN 2MM X 2CM 1 UNIT
MDR report key: 610689
·
Received July 8, 2004
Report
- Report Number
- 1121308-2004-00029
- Event Type
- Other
- Date Received
- July 8, 2004
- Report Date
- July 7, 2004
- Manufacturer
- INTEGRA LIFESCIENCES CORP.
- Product Code
- FZX
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE DEVICES WERE SHIPPED VIA FEDERAL EXPRESS TO THE INCORRECT ADDRESS. THE PT WAS AT THE MEDICAL FACILITY IN THE OPERATING ROOM HOLDING AREA WITH IV STARTED AND THE PROCEDURE HAD TO BE RE-SCHEDULED DUE TO LATE SHIPMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEURAGEN 2MM X 2CM 1 UNIT | NEURAGEN NERVE GUIDE | FZX | INTEGRA LIFESCIENCES CORP. | PNG-220 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |