FDA Adverse Event
Malfunction
Summary report: N
PERCLOSE PROGLIDE
MDR report key: 21111453
·
Received January 9, 2025
Report
- Report Number
- 21111453
- Event Type
- Malfunction
- Date Received
- January 9, 2025
- Date of Event
- December 30, 2024
- Report Date
- January 2, 2025
- Manufacturer
- ABBOTT VASCULAR
- Product Code
- MGB
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MO
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
FAILED MEDICAL DEVICE ABBOTT PERCLOSE PROSTYLE LOT # 4101641 X 3 DEVICES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 379275 | PERCLOSE PROGLIDE | DEVICE, HEMOSTASIS, VASCULAR | MGB | ABBOTT VASCULAR | 12773-03 | 4101641 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |