FDA Adverse Event
Malfunction
Summary report: N
HANAROSTENT® LOWAXTM DUODENUM/PYLORUS(NNN)
MDR report key: 22296625
·
Received June 20, 2025
Report
- Report Number
- 22296625
- Event Type
- Malfunction
- Date Received
- June 20, 2025
- Date of Event
- June 1, 2025
- Report Date
- June 12, 2025
- Manufacturer
- M.I.TECH CO., LTD.
- Product Code
- MUM
- UDI-DI
- 08806367081346
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- VA
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
UNABLE TO USE STENT SINCE THE DEPLOYMENT STRING SNAPPED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1640508 | HANAROSTENT® LOWAXTM DUODENUM/PYLORUS(NNN) | STENT, METALLIC, EXPANDABLE, DUODENAL | MUM | M.I.TECH CO., LTD. | DNJF-22-120-230 | 24082264 | 08806367081346 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Male |