BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART-VALVE, MECHANICAL

    MDR report key: 10487551 · Received September 3, 2020

    Report

    Report Number
    10487551
    Event Type
    Malfunction
    Date Received
    September 3, 2020
    Date of Event
    July 27, 2020
    Report Date
    July 30, 2020
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    LWQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE GRAFT FELL APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953641 HEART-VALVE, MECHANICAL LWQ CRYOLIFE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 27010 DA