BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARBOMEDICS TOP HAT MECHANICAL HEART VALVE

    MDR report key: 12917733 · Received December 2, 2021

    Report

    Report Number
    3019892983-2021-01042
    Event Type
    Death
    Date Received
    December 2, 2021
    Date of Event
    September 24, 2021
    Report Date
    December 2, 2021
    Manufacturer
    CORCYM S.R.L.
    Product Code
    LWQ
    UDI-DI
    08022057012890
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH THE DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, A CARBOMEDICS TOP HAT VALVE S5-019 WAS IMPLANTED ON (B)(6) 2021. THE FORM ALSO INDICATED THAT THE PATIENT PASSED AWAY ON THE SAME DAY. AS REPORTED, THE PATIENT RECEIVED MULTIPLE VALVE REPLACEMENTS. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1816377 CARBOMEDICS TOP HAT MECHANICAL HEART VALVE MECHANICAL HEART VALVE PROSTHESIS LWQ CORCYM S.R.L. CPHV 08022057012890

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Death