FDA Adverse Event
Injury
Summary report: N
TRIGEN TAN D LT LIME
MDR report key: 3061034
·
Received April 16, 2013
Report
- Report Number
- 1020279-2013-00214
- Event Type
- Injury
- Date Received
- April 16, 2013
- Date of Event
- March 12, 2013
- Report Date
- April 12, 2013
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JDS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED WHILE ENGAGING\DISENGAGING THE DEVICE INTRA-OPERATIVELY, THERE WAS A DELAY OF SURGERY TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 162076 | TRIGEN TAN D LT LIME | 13 X 34 130 | JDS | SMITH & NEPHEW, INC. | 05BM19580 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Hospitalization| R | TRIGEN END CAP |