FDA Adverse Event
Malfunction
Summary report: N
REFLEX STR
MDR report key: 3220839
·
Received June 28, 2013
Report
- Report Number
- 3220839
- Event Type
- Malfunction
- Date Received
- June 28, 2013
- Date of Event
- June 11, 2013
- Report Date
- June 28, 2013
- Manufacturer
- CONMED CORPORATION
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- GA, US
- Reporter Occupation
- RISK MANAGER
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 295345 | REFLEX STR | LAPAROSCOPE, GENERAL & PLASTIC SURGERY | GCJ | CONMED CORPORATION | * | 1301041 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR |