FDA Adverse Event
Malfunction
Summary report: N
FLEX 60 ARTICULATING
MDR report key: 2964218
·
Received February 15, 2013
Report
- Report Number
- 3005075853-2013-00530
- Event Type
- Malfunction
- Date Received
- February 15, 2013
- Date of Event
- January 18, 2013
- Report Date
- March 26, 2024
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GDW
- UDI-DI
- 10705036001706
- PMA / PMN Number
- K081146
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 69953 | FLEX 60 ARTICULATING | STAPLE, IMPLANTABLE | GDW | ETHICON ENDO-SURGERY, LLC. | J4CM84 | 10705036001706 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |