MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-10-23 for MST MALYUGIN RING SYSTEM MAL-0001-1 MAL-0001 manufactured by Microsurgical Technology Inc.
[89997691]
The surgeon reported that the patient had preexisting conditions, synechiae, and thought that the iris had swollen as a result of this condition after the malyugin ring had been inserted. There was no further impact to the patient and the procedure was completed as planned.
Patient Sequence No: 1, Text Type: N, H10
[89997692]
The doctor reported that upon removal of the malyugin ring the left scroll was tight and damaged the iris. Patient was reported to be doing fine post-op.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019924-2017-00019 |
| MDR Report Key | 6969603 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-23 |
| Date of Report | 2017-10-20 |
| Date Mfgr Received | 2017-09-25 |
| Device Manufacturer Date | 2015-11-17 |
| Date Added to Maude | 2017-10-23 |
| 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. ROB RANEY |
| 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 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MST MALYUGIN RING SYSTEM |
| Generic Name | CLIP IRIS RETRACTOR |
| Product Code | HOC |
| Date Received | 2017-10-23 |
| Model Number | MAL-0001-1 |
| Catalog Number | MAL-0001 |
| Lot Number | 074114 |
| Device Expiration Date | 2018-11-01 |
| 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 | 1. Other | 2017-10-23 |