BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEMO3D-RECHORD #32

    MDR report key: 11982135 · Received June 11, 2021

    Report

    Report Number
    1718850-2021-01105
    Event Type
    Injury
    Date Received
    June 11, 2021
    Report Date
    June 11, 2021
    Manufacturer
    CORCYM S.R.L.
    Product Code
    KRH
    UDI-DI
    08022057015099
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    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 MEMO 3D RECHORD SEMIRIGID ANNULOPLASTY RING SIZE 32 WAS IMPLANTED ON (B)(6) 2019. IT WAS EXPLANTED ON (B)(6)2021 AND REPLACED WITH A CARBOMEDICS OPTIFORM MITRAL HEART VALVE F7-029. 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
    879424 MEMO3D-RECHORD #32 MEMO 3D RECHORD KRH CORCYM S.R.L. MRCS32 08022057015099

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention