MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-03 for MALYUGIN RING manufactured by Microsurgical Technology Inc.
[44805314]
This report was received via company website inquiry email. Initially contact was made with the materials manager who sent the email however since then, there has been no response from the facility to repeated inquiries. At this time the event cannot be confirmed since there was no evaluation performed and no response from the facility has been received. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[44805315]
The facility reported that iris retractors allegedly broke while being removed from the eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019924-2016-00005 |
| MDR Report Key | 5628909 |
| Date Received | 2016-05-03 |
| Date of Report | 2016-05-02 |
| Date Mfgr Received | 2016-04-05 |
| Date Added to Maude | 2016-05-03 |
| 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. ROBERT MAY |
| 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 |
| Generic Name | CLIP, IRIS RETRACTOR |
| Product Code | HOC |
| Date Received | 2016-05-03 |
| 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 | 2016-05-03 |