MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-05 for MST MALYUGIN RING MAL-1002-1 manufactured by Microsurgical Technology Inc..
[135936004]
Malyugin ring did not deploy correctly prior to insertion. No patient contact or patient information known at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083758 |
| MDR Report Key | 8311471 |
| Date Received | 2019-02-05 |
| Date of Report | 2019-02-03 |
| Date of Event | 2019-01-21 |
| Date Added to Maude | 2019-02-06 |
| 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 | MST MALYUGIN RING |
| Generic Name | CLIP, IRIS RETRACTOR |
| Product Code | HOC |
| Date Received | 2019-02-05 |
| Returned To Mfg | 2019-02-03 |
| Catalog Number | MAL-1002-1 |
| Lot Number | 105094 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2019-02-05 |