BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENGINEERED BICUSPID HEART VALVE

    MDR report key: 4744824 · Received May 1, 2015

    Report

    Report Number
    MW5042437
    Event Type
    Death
    Date Received
    May 1, 2015
    Date of Event
    December 1, 2005
    Manufacturer
    CRYOLIFE
    Product Code
    OHA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    EXPERIMENTAL SURGERIES. PARENTS NOT INFORMED. (B)(6), SEIZURES UNSTOPPABLE. BREAK OUT OF (B)(6) SO BAD IN HER MOUTH (B)(6) 2007; MOUTH COULD NOT CLOSE BECAUSE WHAT LOOKED LIKE A BUNCH OF BLOOD CLOTS. WE WERE NEVER INFORMED OF THESE DISEASES. ENGINEERED VALVE FIRST OF ITS KIND BY CRYOLIFE INC. TISSUE IMPLANTED AT (B)(6) BY DR (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286869 ENGINEERED BICUSPID HEART VALVE CRYOLIFE INC (GEORGIA) OHA CRYOLIFE

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Congenital Anomaly| D| H| L| O| R| S BIO TISSUE HUMAN