MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-03-05 for MALYUGIN RING SYSTEM MAL-0001-1 manufactured by Microsurgical Technology, Inc..
[21844271]
The surgeon reported that three malyugin rings came apart during removal from the eye. There was no impact to the patient.
Patient Sequence No: 1, Text Type: D, B5
[22221397]
The surgeon reported that he is using a method of removal that is contrary to the directions for use. This is the second of three reports.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3019924-2015-00008 |
| MDR Report Key | 4587044 |
| Report Source | 05,06 |
| Date Received | 2015-03-05 |
| Date of Report | 2015-03-03 |
| Date of Event | 2015-02-05 |
| Date Mfgr Received | 2015-02-05 |
| Device Manufacturer Date | 2014-05-01 |
| Date Added to Maude | 2015-04-08 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 8415 154TH AVE., N.E. |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4255560544 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MALYUGIN RING SYSTEM |
| Generic Name | IRIS CLIP RETRACTOR |
| Product Code | HOC |
| Date Received | 2015-03-05 |
| Returned To Mfg | 2015-02-20 |
| Model Number | MAL-0001-1 |
| Catalog Number | MAL-0001-1 |
| Lot Number | 060233 |
| Device Expiration Date | 2017-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROSURGICAL TECHNOLOGY, INC. |
| Manufacturer Address | REDMOND WA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-03-05 |