BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 1120993 · Received August 13, 2008

    Report

    Report Number
    6000002-2008-08402
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 29, 2008
    Report Date
    July 29, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DTI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MAGNA SIZER BROKE DURING USE. REPORTEDLY, THE SURGEON NOTICED THAT THE DEVICE WAS CRACKED; HOWEVER, A PIECE BROKE OFF INTO THE PATIENT'S CHEST WHEN THE SURGEON WAS MANIPULATING THE SIZER WITH FORCEPS. IT WAS REPORTED THAT THE SURGEON WAS ABLE TO RETRIEVE THE PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK SIZER DTI EDWARDS LIFESCIENCES UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK