MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-01-16 for MALYUGIN RING SYSTEM MAL-0002 manufactured by Microsurgical Technology, Inc..
[3371798]
When the surgeon attempted to remove a malyugin ring a small strand of iris became tangled in the ring. The surgeon thought the small strand would tear easily and tugged on the iris causing a tear and bleeding. A second attempt to remove the ring with the inserter was successful.
Patient Sequence No: 1, Text Type: D, B5
[10408689]
The pt? S iris was bound down with synechia. The surgeon cleared the synechia 360 degrees with viscoat and afterward the iris had significant prolapse with one of the eyelets of the ring protruding into the incision. Upon completing cataract removal the ring was disengaged but the iris had a moth-eaten consistency and a portion of the iris had become entangled in the ring resulting in the event. The surgeon reported the incision was too short and four sutures were used to close the wound. The surgeon expected the blood to clear in a couple of months and the pt to fully recover.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3019924-2013-00002 |
| MDR Report Key | 2928885 |
| Report Source | 05 |
| Date Received | 2013-01-16 |
| Date of Report | 2013-01-14 |
| Date of Event | 2012-12-21 |
| Date Added to Maude | 2013-01-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 8415 154TH AVE., N.E. |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4255560544 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MALYUGIN RING SYSTEM |
| Generic Name | IRIS RETRACTOR |
| Product Code | HNI |
| Date Received | 2013-01-16 |
| Model Number | MAL-0002 |
| Catalog Number | MAL-0002 |
| Lot Number | UNKNOWN |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROSURGICAL TECHNOLOGY, INC. |
| Manufacturer Address | REDMOND WA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-01-16 |