MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-01-23 for AORTIC VALVE SIZER 1130 manufactured by Edwards Lifesciences.
[20739576]
Aortic valve sizer broke off in the pt during surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5023953 |
| MDR Report Key | 2430039 |
| Date Received | 2012-01-23 |
| Date of Report | 2012-01-23 |
| Date of Event | 2012-01-20 |
| Date Added to Maude | 2012-01-30 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AORTIC VALVE SIZER |
| Generic Name | AORTIC VALVE SIZER, 27 MM |
| Product Code | DTI |
| Date Received | 2012-01-23 |
| Catalog Number | 1130 |
| ID Number | REF # 1130 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES |
| Manufacturer Address | IRVINE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2012-01-23 |