FDA Adverse Event
Malfunction
Summary report: N
MST
MDR report key: 23372805
·
Received October 23, 2025
Report
- Report Number
- 3019924-2025-00016
- Event Type
- Malfunction
- Date Received
- October 23, 2025
- Report Date
- October 23, 2025
- Manufacturer
- MICROSURGICAL TECHNOLOGY INC
- Product Code
- HOC
- UDI-DI
- 00844685006120
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
2 LOTS WERE AFFECTED #210379 AND 204868 AND THE INFORMATION IN THE FORM IS FOR BOTH THE LOTS.
Description of Event or Problem · 0
CUSTOMER HAD TWO MAL-1001-01 NOT DEPLOY PROPERLY DURING SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2816176 | MST | MALYUGIN RING SYSTEM 2.0 6.25 | HOC | MICROSURGICAL TECHNOLOGY INC | MAL-1001-1 | 210379 204868 | 00844685006120 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |