FDA Adverse Event
Other
Summary report: N
PERCLOSE PROGLIDE 6 FR SMC SYSTEM
MDR report key: 828633
·
Received February 28, 2007
Report
- Report Number
- 2953144-2007-00249
- Event Type
- Other
- Date Received
- February 28, 2007
- Date of Event
- December 26, 2006
- Report Date
- February 6, 2007
- Manufacturer
- ABBOTT VASCULAR INC.
- Product Code
- MGB
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED AND THERE WAS NO LOT INFO. WE WERE NOT ABLE TO PERFORM DEVICE INSPECTION OR DEVICE HISTORY RECORD REVIEW IN THIS CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PERCLOSE PROGLIDE 6 FR SMC SYSTEM | SUTURE MEDIATED CLOSURE | MGB | ABBOTT VASCULAR INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR |