FDA Adverse Event
Other
Summary report: N
MST MALYUGIN RING SYSTEM
MDR report key: 2187523
·
Received July 22, 2011
Report
- Report Number
- 3019924-2011-00017
- Event Type
- Other
- Date Received
- July 22, 2011
- Date of Event
- June 22, 2011
- Report Date
- July 20, 2011
- Manufacturer
- MICROSURGICAL TECHNOLOGY INC
- Product Code
- HNI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED WITH THE DEBRIS. W/O EVALUATING THE DEVICE MST COULD NOT DETERMINE WHERE THE DEBRIS ORIGINATED.
Description of Event or Problem · 1
THE FACILITY REPORTED THAT THE WHEN THE SURGEON WAS INSERTING THE RING INTO THE EYE A PIECE OF YELLOWISH PLASTIC FELL INTO THE EYE. THE PIECE WAS REMOVED W/O HARM TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MST MALYUGIN RING SYSTEM | IRIS CLIP | HNI | MICROSURGICAL TECHNOLOGY INC | MAL-0001 | 039858 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 95 YR | Other| R |