MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2012-02-17 for MST MALYUGIN RING MAL-000-1 manufactured by Mst.
[2552465]
During cataract surgery, left eye, the pupil was noted to be small despite vigorous attempts to dilate. A malyugin ring was inserted easily but when the inserter was removed from the eye, there was a large tear in the anterior capsule extending under the iris. This made the capsule unstable and risk of extension to posterior capsule. It did not extend but the sulcus 10l seemed somewhat unstable - decentering but seemed centered at the end of case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2497824 |
| MDR Report Key | 2497824 |
| Report Source | 99 |
| Date Received | 2012-02-17 |
| Date of Report | 2011-12-22 |
| Date of Event | 2011-12-21 |
| Date Facility Aware | 2011-12-22 |
| Report Date | 2011-12-22 |
| Date Added to Maude | 2012-03-22 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MST MALYUGIN RING |
| Generic Name | MALYUGIN RING |
| Product Code | HNQ |
| Date Received | 2012-02-17 |
| Model Number | MAL-000-1 |
| Lot Number | 039 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MST |
| Manufacturer Address | 8415 154TH AVE., N.E. REDMOND WA 98052 US 98052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-02-17 |