FDA Adverse Event
Other
Summary report: N
NEURAGEN 2MM X 2CM 1 UNIT
MDR report key: 648524
·
Received December 2, 2005
Report
- Report Number
- 1121308-2005-00034
- Event Type
- Other
- Date Received
- December 2, 2005
- Report Date
- December 2, 2005
- Manufacturer
- INTEGRA LIFESCIENCES
- Product Code
- FZX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
THE USER FACILITY ORDERED THE PRODUCT FOR A SCHEDULED PROCEDURE BUT DID NOT RECEIVE IT ON TIME. THE SURGEON HAD TO GRAFT FROM THE PT TO COMPLETE THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEURAGEN 2MM X 2CM 1 UNIT | NEURAGEN | FZX | INTEGRA LIFESCIENCES | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |