BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARBOMEDICS PROSTHETIC HEART VALVE

    MDR report key: 42939 · Received October 18, 1996

    Report

    Report Number
    1627803-1996-00052
    Event Type
    Injury
    Date Received
    October 18, 1996
    Date of Event
    September 9, 1996
    Report Date
    October 18, 1996
    Manufacturer
    CARBOMEDICS, INC.
    Product Code
    LWQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A PT EXPERIENCED A THROMBOEMBOLIC EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARBOMEDICS PROSTHETIC HEART VALVE Implant PROSTHETIC HEART VALVE, MECHANICAL LWQ CARBOMEDICS, INC. 700 C139859-D

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| L| R NO INFO PROVIDED FROM HOSP.