MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2020-03-26 for CARBOMEDICS REDUCED AORTIC VALVE R5-021 manufactured by Sorin Group Italia Srl.
| Report Number | 3005687633-2020-00109 |
| MDR Report Key | 9884808 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-02-25 |
| Device Manufacturer Date | 2019-05-17 |
| Date Added to Maude | 2020-03-26 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. FRANCESCA CROVATO |
| Manufacturer Street | 5005 NORTH FRASER WAY |
| Manufacturer City | BURNABY, BC V5J 5M1 |
| Manufacturer Country | CA |
| Manufacturer Postal | V5J 5M1 |
| Manufacturer G1 | SORIN GROUP ITALIA SRL |
| Manufacturer Street | STRADA CRESCENTINO SNC |
| Manufacturer City | SALUGGIA, VERCELLI 13040 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 13040 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARBOMEDICS REDUCED AORTIC VALVE |
| Generic Name | MECHANICAL HEART VALVE PROSTHESIS |
| Product Code | LWQ |
| Date Received | 2020-03-26 |
| Model Number | R5-021 |
| Catalog Number | R5-021 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SORIN GROUP ITALIA SRL |
| Manufacturer Address | STRADA CRESCENTINO SNC SALUGGIA, VERCELLI 13040 IT 13040 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-03-26 |