BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERIMOUNT MAGNA AORTIC SIZER SET 19MM - 29MM

    MDR report key: 1058156 · Received June 5, 2008

    Report

    Report Number
    6000002-2008-07490
    Event Type
    Other
    Date Received
    June 5, 2008
    Report Date
    May 5, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DTI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    THIS IS A COMPLAINT OF 38 SIZERS THAT ARE SHOWING CRACKING AFTER VERY FEW USED. HOWEVER, THESE ARE NOT REPORTED TO HAVE PIECES MISSING. DEVICE FOR HVT HANDLE/SIZER FRACTURES HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERIMOUNT MAGNA AORTIC SIZER SET 19MM - 29MM AORTIC SIZER DTI EDWARDS LIFESCIENCES 1130SET UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other