MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-24 for MALYUGIN RING MAL-0001-1 manufactured by Microsurgical Technology, Inc..
[118410631]
Surgeon noted a piece of what appeared to be plastic in dye of pt s/p removal of malyugin ring, foreign body retrieved per surgeon with use of microscope. Eye exam completed and cleared per surgeon. After procedure, surgeon opened a new malyugin ring to compare the device with the device used intra-op and surgeon suspects that the original device was faulty, and a piece broke off during use in pt's eye, no injury noted to pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079397 |
| MDR Report Key | 7818607 |
| Date Received | 2018-08-24 |
| Date of Report | 2018-08-23 |
| Date of Event | 2018-08-15 |
| Date Added to Maude | 2018-08-27 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MALYUGIN RING |
| Generic Name | MALYUGIN RING |
| Product Code | HOC |
| Date Received | 2018-08-24 |
| Model Number | MAL-0001-1 |
| Lot Number | 097908 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROSURGICAL TECHNOLOGY, INC. |
| Manufacturer Address | REDMOND WA 98052 US 98052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-24 |