BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARBOMEDICS PROSTHETIC HEART VALVE

    MDR report key: 36300 · Received August 30, 1996

    Report

    Report Number
    1627803-1996-00050
    Event Type
    Injury
    Date Received
    August 30, 1996
    Date of Event
    July 19, 1996
    Report Date
    August 30, 1996
    Manufacturer
    CARBOMEDICS, INC.
    Product Code
    LWQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS: PT FACTOR CONTRIBUTED TO FORMATION OF THROMBOSIS. NO FAILURE DETECTED AND PRODUCT WITHIN SPECS. A MFG RECORDS REVIEW CONFIRMED THIS VALVE SATISFIED ALL MATERIAL, DIMENSIONAL AND PERFORMANCE REQUIREMENTS AT THE TIME OF MFR AND RELEASE.

    Description of Event or Problem · 1

    THE VALVE HAS BEEN EXPLANTED.

    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 A237096-F

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| L| R