BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1174 PHYSIO ANNULOPLASTY RING SIZER

    MDR report key: 920713 · Received September 26, 2007

    Report

    Report Number
    6000002-2007-05194
    Event Type
    Malfunction
    Date Received
    September 26, 2007
    Date of Event
    September 10, 2007
    Report Date
    September 10, 2007
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    REPORTEDLY, AFTER SIX MONTHS OF USE AND FLOWING DFU FOR STERILIZATION THE CUSTOMER REPORTS THESE DEVICES TO HAVE CRACKS AND PIECES MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1174 PHYSIO ANNULOPLASTY RING SIZER ANNULOPLASTY RING SIZER DWS EDWARDS LIFESCIENCES 1174PHY NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR