MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-11-04 for MALYUGIN RING SYSTEM MAL-0001-1 manufactured by Microsurgical Technology, Inc..
[17946494]
The surgeon reported that she had experienced several malyugin rings hanging on the iris upon retraction into the cannula as well as other rings that broke upon retraction.
Patient Sequence No: 1, Text Type: D, B5
[18131160]
The report of broken rings or patient impact could not be confirmed with any of the facility staff that the doctor reference in her report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3019924-2014-00048 |
| MDR Report Key | 4268513 |
| Report Source | 05 |
| Date Received | 2014-11-04 |
| Date of Report | 2014-10-30 |
| Date Mfgr Received | 2014-10-14 |
| Date Added to Maude | 2014-11-25 |
| 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 NE |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4255560544 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MALYUGIN RING SYSTEM |
| Generic Name | IRIS CLIP RETRACTOR |
| Product Code | HOC |
| Date Received | 2014-11-04 |
| Model Number | MAL-0001-1 |
| Catalog Number | MAL-0001-1 |
| 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 | 2014-11-04 |