MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-29 for CARBOMEDICS TOP HAT PROSTHETIC HEART VALVE S5-023 manufactured by Sorin Group Italia S.r.l..
[186273808]
On (b)(6) 2011 a patient received a carbomedics top hat s5-023 mechanical heart valve. The manufacturer was notified that on (b)(6) 2019 the device was removed and replaced with another valve. No further information was received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1718850-2020-01052 |
| MDR Report Key | 9896223 |
| Date Received | 2020-03-29 |
| Date of Report | 2020-03-29 |
| Date of Event | 2019-12-10 |
| Date Facility Aware | 2020-02-28 |
| Report Date | 2020-02-28 |
| Date Reported to Mfgr | 2020-02-28 |
| Date Mfgr Received | 2020-02-28 |
| Date Added to Maude | 2020-03-29 |
| 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 PROSTHETIC HEART VALVE |
| Generic Name | MECHANICAL HEART VALVE PROSTHESIS |
| Product Code | LWQ |
| Date Received | 2020-03-29 |
| Model Number | S5-023 |
| Catalog Number | S5-023 |
| Device Expiration Date | 2015-09-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 9 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, VC 13040 IT 13040 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-29 |