MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-12-16 for MALYUGIN RING SYSTEM MAL-0001-1 manufactured by Microsurgical Technology, Inc..
[5112801]
It was reported that a small piece of plastic was injected into the eye with a malyugin ring. Reporting site indicated that the doctor retrieved the plastic and that there was no patient impact.
Patient Sequence No: 1, Text Type: D, B5
[12626064]
Analysis of particle to date is inconclusive as to origin. It is unlikely that this particle came from the malyugin ring system. Visually the particle does not match the malyugin ring, and the injector system does not show evidence of missing pieces.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3019924-2014-00058 |
| MDR Report Key | 4357959 |
| Report Source | 05,06 |
| Date Received | 2014-12-16 |
| Date of Report | 2014-12-16 |
| Date Mfgr Received | 2014-11-17 |
| Device Manufacturer Date | 2014-09-01 |
| Date Added to Maude | 2014-12-31 |
| 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 |
| 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 | 2014-12-16 |
| Returned To Mfg | 2014-12-05 |
| Model Number | MAL-0001-1 |
| Catalog Number | MAL-0001-1 |
| Lot Number | 063889 |
| Device Expiration Date | 2017-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROSURGICAL TECHNOLOGY, INC. |
| Manufacturer Address | REDMOND WA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-16 |