FDA Adverse Event
Malfunction
Summary report: N
SUTURE EASE FASCIAL CLOSURE SYSTEM
MDR report key: 21147676
·
Received January 14, 2025
Report
- Report Number
- 21147676
- Event Type
- Malfunction
- Date Received
- January 14, 2025
- Date of Event
- December 10, 2024
- Report Date
- January 8, 2025
- Manufacturer
- SUTURE EASE, INC.
- Product Code
- OCW
- UDI-DI
- 0086825000320
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- TN
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
DEVICE BROKE WHILE TRYING TO CLOSE THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1485767 | SUTURE EASE FASCIAL CLOSURE SYSTEM | ENDOSCOPIC TISSUE APPROXIMATION DEVICE | OCW | SUTURE EASE, INC. | CB240701 | 0086825000320 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Female |