FDA Adverse Event
Injury
Summary report: N
133650 PREMIUM SURGICLIP III 9.0
MDR report key: 6255956
·
Received January 17, 2017
Report
- Report Number
- 2647580-2017-00050
- Event Type
- Injury
- Date Received
- January 17, 2017
- Date of Event
- November 8, 2016
- Report Date
- December 12, 2016
- Manufacturer
- COVIDIEN, FORMERLY USSC PUERTO RICO INC
- Product Code
- FZP
- UDI-DI
- 10884521517394
- PMA / PMN Number
- K142869
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). (B)(6). (B)(4).
Description of Event or Problem · 1
ACCORDING TO THE REPORTER, DURING A BREAST RECONSTRUCTION, THE PATIENT HAD TO HAVE ANOTHER OPERATION DUE TO AN INTERNAL HEMORRHAGE. THE CLIPS HAD NOT CLAMPED CORRECTLY IN SOME MAMMARY ARTERIES. FOR THE RE-OPERATION, THEY USED A DIFFERENT PRODUCT TO SOLVE THE PROBLEM. THERE WAS LESS THAN A 30 MINUTE DELAY AND LESS THAN 500CC OF BLOOD LOSS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 39838 | 133650 PREMIUM SURGICLIP III 9.0 | CLIP, IMPLANTABLE | FZP | COVIDIEN, FORMERLY USSC PUERTO RICO INC | 133650 | 10884521517394 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |