FDA Adverse Event
Injury
Summary report: N
MST MALYUGIN RING SYSTEM
MDR report key: 7108572
·
Received December 12, 2017
Report
- Report Number
- 3019924-2017-00022
- Event Type
- Injury
- Date Received
- December 12, 2017
- Report Date
- December 12, 2017
- Manufacturer
- MICROSURGICAL TECHNOLOGY INC
- Product Code
- HOC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
DURING A TRADE SHOW PRESENTATION THE MANUFACTURERS ENGINEER ALLEGEDLY HEARD THAT A MALYUGIN RING WAS USED IN A SURGERY IN WHICH THE SURGEON ALLEGEDLY EXPERIENCED A CAPSULE TEAR.
Description of Event or Problem · 1
DURING CATARACT SURGERY THE SURGEON EXPERIENCED AN ANTERIOR CAPSULE TEAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 888758 | MST MALYUGIN RING SYSTEM | IRIS RETRACTOR | HOC | MICROSURGICAL TECHNOLOGY INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |