MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-06-26 for MALYUGIN RING SYSTEM MAL-0001-1 manufactured by Microsurgical Technology, Inc..
[112457252]
The surgery was a complex cataract surgery with lens implant. The ring entangled with the iol complex. The ring was cut and partially removed. No follow-up procedure is scheduled at this time.
Patient Sequence No: 1, Text Type: N, H10
[112457253]
During a complex cataract surgery, the malyugin ring entangled with the iol complex. The malyugin ring was cut, and half of the ring was removed, the other half was left in the eye. There will not be a follow-up surgery scheduled at this time. Patient status is unknown at this time due to confidentiality requirements at the facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019924-2018-00021 |
| MDR Report Key | 7639639 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-06-26 |
| Date of Report | 2018-06-22 |
| Date Mfgr Received | 2018-05-29 |
| Date Added to Maude | 2018-06-26 |
| 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. CECIL CHRISINGER |
| 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 | 3 |
| Brand Name | MALYUGIN RING SYSTEM |
| Generic Name | CLIP, IRIS RETRACTOR |
| Product Code | HOC |
| Date Received | 2018-06-26 |
| Model Number | MAL-0001-1 |
| Catalog Number | MAL-0001-1 |
| 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 | 1. Other | 2018-06-26 |