MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-16 for MALYUGIN RING SYSTEM MAL-1002-1 manufactured by Microsurgical Technology Inc.
[63070906]
The doctor reported that there was no impact to the patient. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[63070907]
The surgeon reported that during removal of the malyugin ring the ring flip upward touching the endothelium cells. There was no reported impact to the patient and the procedure was completed as planned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019924-2016-00022 |
| MDR Report Key | 6183529 |
| Date Received | 2016-12-16 |
| Date of Report | 2016-12-16 |
| Date Mfgr Received | 2016-12-02 |
| Date Added to Maude | 2016-12-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MR. JOHN RAY |
| Manufacturer Street | 8415 154TH AVE NE |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4255560544 |
| Manufacturer G1 | MICROSURGICAL TECHNOLOGY INC |
| Manufacturer Street | 8415 154TH AVE NE |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98052 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MALYUGIN RING SYSTEM |
| Generic Name | CLIP IRIS RETRACTOR |
| Product Code | HOC |
| Date Received | 2016-12-16 |
| Model Number | MAL-1002-1 |
| Catalog Number | MAL-1002-1 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROSURGICAL TECHNOLOGY INC |
| Manufacturer Address | 8415 154TH AVE NE REDMOND WA 98052 US 98052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-16 |