FDA Adverse Event
Malfunction
Summary report: N
SUTURELASSO
MDR report key: 3200860
·
Received June 21, 2013
Report
- Report Number
- 3200860
- Event Type
- Malfunction
- Date Received
- June 21, 2013
- Date of Event
- May 1, 2013
- Report Date
- June 21, 2013
- Manufacturer
- ARTHREX, INC.
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- IL, US
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 282451 | SUTURELASSO | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | LXH | ARTHREX, INC. | * | 302639265 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR |