BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARPENTIER-EDWARDS PHYSIO

    MDR report key: 2945538 · Received January 25, 2013

    Report

    Report Number
    2945538
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    August 28, 2012
    Report Date
    January 25, 2013
    Manufacturer
    EDWARDS LIFE SCIENCES
    Product Code
    KRH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    ANNULOPLASTY RING WAS TORN APPROXIMATELY 2MM ON THE SIDE OF THE RING. THE LOCATION OF THE TEAR WAS BY THE SILK SUTURE LINE. LIFTING THE RING BY THE BLUE ATTACHED TAG TO CUT THE BLACK SUTURE INCREASED THE TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36476 CARPENTIER-EDWARDS PHYSIO RING, ANNULOPLASTY KRH EDWARDS LIFE SCIENCES MITRAL MODEL 4450 3485073

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR