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-0002-1 manufactured by Microsurgical Technology, Inc..
[22151400]
The doctor reported that he had experienced malyugin rings breaking at the glue joint upon removal from the eye. There was no impact to the patient and the procedure was completed as planned. There were other unsubstantiated reports of malyugin rings breaking from the facility.
Patient Sequence No: 1, Text Type: D, B5
[22271296]
The surgeon reported that he was using forceps to remove the ring from the eye contrary to the instructions for use which instruct to use the inserter for removal. At the time of this report no product had been returned for evaluation and no information about this or any other ring breaks was available. This is the third of four reports.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3019924-2015-00005 |
| MDR Report Key | 4589712 |
| Report Source | 05,06 |
| Date Received | 2015-03-05 |
| Date of Report | 2015-03-03 |
| Device Manufacturer Date | 2014-10-01 |
| Date Added to Maude | 2015-04-14 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 |
| Model Number | MAL-0002-1 |
| Catalog Number | MAL-0002-1 |
| Lot Number | 064285 |
| Device Expiration Date | 2017-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 |