FDA Adverse Event
Malfunction
Summary report: N
ETHIOCON
MDR report key: 1313096
·
Received February 9, 2009
Report
- Report Number
- 1313096
- Event Type
- Malfunction
- Date Received
- February 9, 2009
- Report Date
- November 21, 2008
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- User Facility report
Narratives
Description of Event or Problem · 1
TROCARS PACKAGED AND PIECES FLOATING IN PACKAGING. ENDOPATH XCEL 12. RETURNED TO REP ON 11/21/2008.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETHIOCON | TROCARS | GCJ | A148679 | |||
| 2 | ETHICON | TROCARS | GCJ | A186388 | |||
| 3 | ETHICON | TROCARS | GCJ | A187673 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |