MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-04-07 for MALYUGIN RING 7.0 MM MAL-0002-1 manufactured by Microsurgical Technology.
[5828277]
After using the malyugin ring, surgeon demonstrated to resident how to use it properly when a piece of it broke off. There was no patient contact when the piece broke off, and it did not cause any harm to the patient as it was not near the patient when this happened.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4735605 |
| MDR Report Key | 4735605 |
| Date Received | 2015-04-07 |
| Date of Report | 2015-04-07 |
| Date of Event | 2015-03-03 |
| Report Date | 2015-04-07 |
| Date Reported to FDA | 2015-04-07 |
| Date Reported to Mfgr | 2015-04-29 |
| Date Added to Maude | 2015-04-29 |
| 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 |
| Generic Name | CLIP, IRIS RETRACTOR |
| Product Code | HOC |
| Date Received | 2015-04-07 |
| Model Number | 7.0 MM |
| Catalog Number | MAL-0002-1 |
| Lot Number | 066138 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROSURGICAL TECHNOLOGY |
| Manufacturer Address | 8415 154TH AVENUE NE REDMOND, WA 98052 US 98052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-07 |