FDA Adverse Event
Injury
Summary report: N
PREMIUM SURGICLIP L-13.0 TITANIUM
MDR report key: 2757062
·
Received September 18, 2012
Report
- Report Number
- 2647580-2012-00591
- Event Type
- Injury
- Date Received
- September 18, 2012
- Date of Event
- July 5, 2012
- Report Date
- September 3, 2012
- Manufacturer
- COVIDIEN
- Product Code
- FZP
- PMA / PMN Number
- K853650
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INITIAL REPORT SENT TO FDA ON 09/18/2012.
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: A CLIP CUT A VESSEL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PREMIUM SURGICLIP L-13.0 TITANIUM | DISPOSABLE CLIP APPLIER | FZP | COVIDIEN | PIL0613X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |