MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2013-03-27 for MALYUGIN RING SYSTEM MAL-0002 manufactured by Microsurgical Technology Inc.
[16915840]
The customer reported that the malyugin ring system they received was deformed in the packaging. There was no patient contact.
Patient Sequence No: 1, Text Type: D, B5
[17087735]
This report is in response to mdr #(b)(4) received from fda on 03/14/2013. The initial processing of this complaint from the customer determined that it was not a reportable incident at the time received (b)(4) 2012. Only the inserter handle portion of the device was returned without the packaging, cassette or malyugin ring making analysis impossible.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3019924-2013-00011 |
| MDR Report Key | 3149677 |
| Report Source | 00,06 |
| Date Received | 2013-03-27 |
| Date of Report | 2013-03-26 |
| Date of Event | 2012-05-23 |
| Date Mfgr Received | 2013-03-14 |
| Device Manufacturer Date | 2012-03-01 |
| Date Added to Maude | 2013-06-10 |
| 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 NE |
| 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 RETRACTOR |
| Product Code | HNI |
| Date Received | 2013-03-27 |
| Returned To Mfg | 2012-05-30 |
| Model Number | MAL-0002 |
| Catalog Number | MAL-0002 |
| Lot Number | 045976 |
| ID Number | NA |
| Device Expiration Date | 2015-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2013-03-27 |