FDA Adverse Event
Death
Summary report: N
SURGIPRO II 6/0 24 BLUE KV-11 D/A
MDR report key: 3170049
·
Received June 4, 2013
Report
- Report Number
- 1219930-2013-00417
- Event Type
- Death
- Date Received
- June 4, 2013
- Date of Event
- March 17, 2006
- Report Date
- May 6, 2013
- Manufacturer
- COVIDIEN, FORMERLY US
- Product Code
- GAW
- PMA / PMN Number
- K010909
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ON (B)(6) 2006 A RIGHT CAROTID ENDARTERECTOMY WAS PERFORMED DEHISCENCE OF THE THREAD WHICH CAUSED A BLEEDING ACUTE, THE PATIENT DIED ON (B)(6) 2006.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 247477 | SURGIPRO II 6/0 24 BLUE KV-11 D/A | SURGIPRO SUTURE | GAW | COVIDIEN, FORMERLY US |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Death |