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..
[3174250]
Applicator would not hold the ring. What was the original intended procedure? Cataract extraction with implant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2982155 |
| MDR Report Key | 2982155 |
| Date Received | 2013-02-18 |
| Date of Report | 2012-11-15 |
| Date of Event | 2012-09-12 |
| 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 | 3 |
| 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 | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| 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 |