FDA Adverse Event
Malfunction
Summary report: N
DURACLIP(TM) REPOSITIONABLE HEMOSTASIS CLIP
MDR report key: 21263101
·
Received January 29, 2025
Report
- Report Number
- 21263101
- Event Type
- Malfunction
- Date Received
- January 29, 2025
- Date of Event
- December 10, 2024
- Report Date
- January 23, 2025
- Manufacturer
- TRANSMED (CHINA) CO., LTD.
- Product Code
- PKL
- UDI-DI
- 16932619740033
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- VA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
TISSUE CLIP MISFIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 808986 | DURACLIP(TM) REPOSITIONABLE HEMOSTASIS CLIP | HEMOSTATIC METAL CLIP FOR THE GI TRACT | PKL | TRANSMED (CHINA) CO., LTD. | DC0235W | M220424592 | 16932619740033 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Male |