MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-10 for MALYUGIN RING manufactured by Microsurgical Technology.
[20325716]
Malyugin ring was placed during cataract surgery. A malyugin ring breakage occurred upon removal from the eye. Damage to lenticular zonules and capsule occurred. Dislocation of iol was noted postoperatively.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5038169 |
| MDR Report Key | 4092936 |
| Date Received | 2014-09-10 |
| Date of Report | 2014-09-10 |
| Date of Event | 2014-08-11 |
| Date Added to Maude | 2014-09-17 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MALYUGIN RING |
| Product Code | HNQ |
| Date Received | 2014-09-10 |
| Model Number | MALYUGIN RING |
| Lot Number | 061104 |
| Device Expiration Date | 2017-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROSURGICAL TECHNOLOGY |
| Manufacturer Address | REDMOND 98052 98052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-09-10 |