MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-06 for MAGNA MITRAL EASE manufactured by Edwards Lifesciences Llc.
[44568767]
Patient Sequence No: 1, Text Type: N, H10
[44568768]
Aortic manganese 25mm sizer broke off sizer handle. All pieces retrieved. Secured in biohazard bag and returned to rep for reporting.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5636567 |
| MDR Report Key | 5636567 |
| Date Received | 2016-05-06 |
| Date of Report | 2016-04-19 |
| Date of Event | 2016-03-09 |
| Report Date | 2016-04-19 |
| Date Reported to FDA | 2016-04-19 |
| Date Reported to Mfgr | 2016-04-19 |
| Date Added to Maude | 2016-05-06 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Brand Name | MAGNA MITRAL EASE |
| Generic Name | SIZER, HEART-VALVE, PROSTHESIS |
| Product Code | DTI |
| Date Received | 2016-05-06 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES LLC |
| Manufacturer Address | ONE EDWARDS WAY IRVINE, CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-06 |