MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-02-18 for MALYUGIN RING SYSTEM * MAL-0002-1 manufactured by Microsurgical Technologies, Inc..
[3131157]
While still in the package it was noticed that the malyugin ring was deformed. Product was not used. What was the original intended procedure? Cataract extraction with implant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2982154 |
| MDR Report Key | 2982154 |
| Date Received | 2013-02-18 |
| Date of Report | 2012-11-15 |
| Date of Event | 2012-05-23 |
| Report Date | 2012-11-15 |
| Date Reported to FDA | 2013-02-18 |
| Date Reported to Mfgr | 2013-02-28 |
| Date Added to Maude | 2013-02-28 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MALYUGIN RING SYSTEM |
| Generic Name | RETRACTOR, OPHTHALMIC |
| Product Code | HNI |
| Date Received | 2013-02-18 |
| Model Number | * |
| Catalog Number | MAL-0002-1 |
| Lot Number | 045976 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROSURGICAL TECHNOLOGIES, INC. |
| Manufacturer Address | 8415 154TH AVENUE NE REDMOND WA 98052 US 98052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-18 |