FDA Adverse Event
Malfunction
Summary report: N
ECHELON*FLEX60
MDR report key: 1972855
·
Received January 28, 2011
Report
- Report Number
- 1527736-2011-00026
- Event Type
- Malfunction
- Date Received
- January 28, 2011
- Date of Event
- December 9, 2010
- Report Date
- January 3, 2011
- Manufacturer
- ETHICON ENDO SURGERY, INC (CINCINNATI)
- Product Code
- GDW
- PMA / PMN Number
- K081146
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Additional Manufacturer Narrative · 1
(B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ECHELON*FLEX60 | STAPLE, IMPLANTABLE | GDW | ETHICON ENDO SURGERY, INC (CINCINNATI) | UNK | G4U65P |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |