MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-05-16 for MST MALYUGIN RING SYSTEM MAL-0001 manufactured by Microsurgical Technology, Inc..
[18223474]
The surgeon reported that the ring was apparently broken during or prior to removal from the iris at the conclusion of cataract surgery, and became entangled with the iris. Further efforts to remove the ring resulted in damage to the iris. The product was not returned for evaluation, and the pt was reported to have had a good outcome.
Patient Sequence No: 1, Text Type: D, B5
[18351861]
Product was not returned. User declined to provide specific product or pt details. Unable to duplicate in simulated use. Specific lot # involved in event was not provided. Subsequent attempts to contact the user have been unsuccessful.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3019924-2009-00001 |
| MDR Report Key | 1386438 |
| Report Source | 07 |
| Date Received | 2009-05-16 |
| Date of Report | 2009-05-15 |
| Date of Event | 2009-04-15 |
| Date Mfgr Received | 2009-04-15 |
| Date Added to Maude | 2009-05-21 |
| 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 | MST MALYUGIN RING SYSTEM |
| Generic Name | IRIS RETRACTOR |
| Product Code | HNI |
| Date Received | 2009-05-16 |
| Model Number | MAL-0001 |
| Catalog Number | MAL-0001 |
| Lot Number | NOT PROVIDED |
| 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. Required No Informationntervention | 2009-05-16 |