MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-07-22 for MST MALYUGIN RING SYSTEM MAL-0001 manufactured by Microsurgical Technology Inc.
[2044824]
The facility reported that the when the surgeon was inserting the ring into the eye a piece of yellowish plastic fell into the eye. The piece was removed w/o harm to the pt.
Patient Sequence No: 1, Text Type: D, B5
[9150920]
The device was not returned with the debris. W/o evaluating the device mst could not determine where the debris originated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3019924-2011-00017 |
| MDR Report Key | 2187523 |
| Report Source | 06 |
| Date Received | 2011-07-22 |
| Date of Report | 2011-07-20 |
| Date of Event | 2011-06-22 |
| Date Mfgr Received | 2011-06-22 |
| Device Manufacturer Date | 2010-12-01 |
| Date Added to Maude | 2012-06-19 |
| 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 | MST MALYUGIN RING SYSTEM |
| Generic Name | IRIS CLIP |
| Product Code | HNI |
| Date Received | 2011-07-22 |
| Model Number | MAL-0001 |
| Catalog Number | MAL-0001 |
| Lot Number | 039858 |
| Device Expiration Date | 2013-12-01 |
| 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; 2. Required No Informationntervention | 2011-07-22 |