MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-04-13 for MST MALYUGIN RING SYSTEM MAL-0002 manufactured by Microsurgical Technology, Inc..
[2747753]
Facility reported that the glue joint came apart upon removal of the ring. There was no pt or procedural impact.
Patient Sequence No: 1, Text Type: D, B5
[9807394]
At the time of this report, more info is needed to accurately evaluate and determine the cause of this failure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3019924-2012-00006 |
| MDR Report Key | 2557738 |
| Report Source | 06 |
| Date Received | 2012-04-13 |
| Date of Report | 2012-04-13 |
| Date of Event | 2012-03-15 |
| Date Mfgr Received | 2012-03-15 |
| Device Manufacturer Date | 2011-05-01 |
| Date Added to Maude | 2012-09-11 |
| 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 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MST MALYUGIN RING SYSTEM |
| Generic Name | IRIS RETRACTOR |
| Product Code | HNI |
| Date Received | 2012-04-13 |
| Returned To Mfg | 2012-03-23 |
| Model Number | MAL-0002 |
| Catalog Number | MAL-0002 |
| Lot Number | 041696 |
| Device Expiration Date | 2014-05-01 |
| Device Availability | R |
| 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 | 2012-04-13 |