MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-12-09 for MALYUGIN RING * manufactured by Micro Surgical Technology.
[1824377]
The malyugin ring was deployed out of the inserter. It was noted by the surgeon that two of the four diamond shaped edges had kinks which caused the ring to become too tight on the patient's iris. The surgeon removed the ring without harm to the patient's eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1939739 |
| MDR Report Key | 1939739 |
| Date Received | 2010-12-09 |
| Date of Report | 2010-12-09 |
| Date of Event | 2010-11-18 |
| Report Date | 2010-12-09 |
| Date Reported to FDA | 2010-12-09 |
| Date Added to Maude | 2010-12-28 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MALYUGIN RING |
| Generic Name | PUPIL EXPANSION DEVICE |
| Product Code | HNQ |
| Date Received | 2010-12-09 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 038069 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICRO SURGICAL TECHNOLOGY |
| Manufacturer Address | 8415 154TH AVE. NE REDMOND WA 98052 US 98052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-09 |