FDA Adverse Event
Malfunction
Summary report: N
ABBOTT VASCULAR PERCLOSE
MDR report key: 6710518
·
Received July 11, 2017
Report
- Report Number
- MW5070954
- Event Type
- Malfunction
- Date Received
- July 11, 2017
- Date of Event
- June 6, 2017
- Report Date
- June 27, 2017
- Manufacturer
- ABBOTT
- Product Code
- MGB
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- IL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PERCLOSE FOOT BROKE OFF IN THE PT REQUIRING SURGICAL INTERVENTION TO RETRIEVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 485138 | ABBOTT VASCULAR PERCLOSE | PERCLOSE DEVICE | MGB | ABBOTT | 12673-03 | 7012741 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR |