BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARBOMEDICS PROSTHETIC HEART VALVE

    MDR report key: 48348 · Received November 13, 1996

    Report

    Report Number
    1627803-1996-00055
    Event Type
    Injury
    Date Received
    November 13, 1996
    Date of Event
    October 3, 1996
    Report Date
    November 13, 1996
    Manufacturer
    CARBOMEDICS, INC.
    Product Code
    LWQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN AORTIC DEVICE WAS EXPLANTED AND REPLACED DUE TO A SUSPECTED LEAFLET IMMOBILITY. PROPER VALVE FUNCTION WAS NOT VERIFIED AT THE TIME OF IMPLANT. IT WAS REPLACED WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARBOMEDICS PROSTHETIC HEART VALVE Implant PROSTHETIC HEART VALVE, MECHANICAL LWQ CARBOMEDICS, INC. 500 C116557-B

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| L| R INFO NOT RELEASED BY HOSP