MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-05-08 for MST MALYUGIN RING SYSTEM MAL-0001-1 MAL-0001 manufactured by Microsurgical Technology.
[20637127]
The facility reported that upon completion of the cataract surgery the doctor was removing the malyugin ring from the eye when the ring broke at the glue joint. The ting was removed and there was no impact to the pt.
Patient Sequence No: 1, Text Type: D, B5
[20902443]
The evaluation of the device showed that the ring fractured at the glue joint. The inserter passed function testing. No conclusions can be drawn regarding the malfunction.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3019924-2013-00021 |
| MDR Report Key | 3109295 |
| Report Source | 06 |
| Date Received | 2013-05-08 |
| Date of Report | 2013-05-07 |
| Date Mfgr Received | 2013-04-12 |
| Date Added to Maude | 2013-07-15 |
| 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 | 0 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MST MALYUGIN RING SYSTEM |
| Generic Name | IRIS CLIP, RETRACTOR |
| Product Code | HNI |
| Date Received | 2013-05-08 |
| Returned To Mfg | 2013-05-02 |
| Model Number | MAL-0001-1 |
| Catalog Number | MAL-0001 |
| Lot Number | 051326 |
| Device Expiration Date | 2016-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROSURGICAL TECHNOLOGY |
| Manufacturer Address | REDMOND WA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-08 |