MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-05-04 for MST MALYUGIN RING SYSTEM MAL-0001 manufactured by Microsurgical Technology, Inc..
[2103288]
The surgeon reported that a malyugin ring had kinks in two corners which caused the device to be too tight on the iris. The ring was removed without harm to the pt.
Patient Sequence No: 1, Text Type: D, B5
[9249151]
Device was not returned for eval. Upon making contact with the facility, they indicated that the surgeon said that one of the scrolls was deformed. There was no pt impact.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3019924-2010-00007 |
| MDR Report Key | 2163784 |
| Report Source | 06 |
| Date Received | 2011-05-04 |
| Date of Report | 2011-05-04 |
| Date of Event | 2010-11-18 |
| Date Mfgr Received | 2010-12-22 |
| Device Manufacturer Date | 2010-08-01 |
| Date Added to Maude | 2012-03-30 |
| 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 | 2011-05-04 |
| Model Number | MAL-0001 |
| Catalog Number | MAL-0001 |
| Lot Number | 038069 |
| Device Expiration Date | 2013-07-31 |
| 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. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-05-04 |