FDA Adverse Event
Malfunction
Summary report: N
CLIP, IMPLANTABLE
MDR report key: 1993554
·
Received February 16, 2011
Report
- Report Number
- 3005075853-2011-00660
- Event Type
- Malfunction
- Date Received
- February 16, 2011
- Date of Event
- December 10, 2010
- Report Date
- January 20, 2011
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- FZP
- PMA / PMN Number
- K050344
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLIP, IMPLANTABLE | FZP | ETHICON ENDO-SURGERY, LLC. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |