MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-11 for CARBOMEDICS TOP HAT MECHANICAL HEART VALVE S5-021 manufactured by Sorin Group Italia S.r.l..
| Report Number | 1718850-2020-01028 |
| MDR Report Key | 9822007 |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date of Event | 2016-08-24 |
| Date Facility Aware | 2020-02-13 |
| Report Date | 2020-02-13 |
| Date Reported to Mfgr | 2020-02-13 |
| Date Mfgr Received | 2020-02-13 |
| Date Added to Maude | 2020-03-11 |
| Event Key | 0 |
| Report Source Code | Distributor 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 |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARBOMEDICS TOP HAT MECHANICAL HEART VALVE |
| Generic Name | MECHANICAL HEART VALVE PROSTHESIS |
| Product Code | LWQ |
| Date Received | 2020-03-11 |
| Model Number | S5-021 |
| Catalog Number | S5-021 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SORIN GROUP ITALIA S.R.L. |
| Manufacturer Address | STRADA CRESCENTINO SNC SALUGGIA, VERCELLI 13040 IT 13040 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-11 |