MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-23 for MALYUGIN RING MAL-0002 manufactured by Microsurgical Technology Inc.
[46862950]
The device was returned in a condition that made it impossible to determine the cause of the alleged malfunction. The complaint could not be confirmed as a result. There was no impact to the patient and the procedure was completed as planned.
Patient Sequence No: 1, Text Type: N, H10
[46862951]
The facility reported that iris retractors allegedly broke while being removed from the eye. There was no impact to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019924-2016-00007 |
| MDR Report Key | 5673944 |
| Date Received | 2016-05-23 |
| Date of Report | 2016-05-20 |
| Date of Event | 2016-04-26 |
| Date Mfgr Received | 2016-05-04 |
| Device Manufacturer Date | 2016-02-10 |
| Date Added to Maude | 2016-05-23 |
| 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. 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 | IRIS RETRACTOR |
| Product Code | HOC |
| Date Received | 2016-05-23 |
| Returned To Mfg | 2016-05-13 |
| Model Number | MAL-0002 |
| Catalog Number | MAL-0002 |
| Lot Number | 075937 |
| Device Expiration Date | 2019-02-01 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-05-23 |