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 |