BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, AORTIC

    MDR report key: 12008796 · Received June 16, 2021

    Report

    Report Number
    1718850-2021-01110
    Event Type
    Injury
    Date Received
    June 16, 2021
    Date of Event
    February 3, 2021
    Report Date
    June 16, 2021
    Manufacturer
    CORCYM S.R.L.
    Product Code
    LWQ
    UDI-DI
    08022057012630
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH THE DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, A CARBOMEDICS STANDARD AORTIC HEART VALVE A5-025 WAS IMPLANTED ON (B)(6) 2020. IT WAS EXPLANTED ON (B)(6) 2021 AND REPLACED WITH CARBOMEDICS REDUCED AORTIC HEART VALVE R5-023. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE. NO ALLEGATION OF A DEVICE MALFUNCTION NOR OF A SERIOUS INJURY WAS RECEIVED FROM THE SITE REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903089 CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, AORTIC MECHANICAL HEART VALVE PROSTHESIS LWQ CORCYM S.R.L. CPHV 08022057012630

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention