BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARD LIFESCIENCE (BARD)

    MDR report key: 1071613 · Received July 8, 2008

    Report

    Report Number
    MW5007583
    Event Type
    Malfunction
    Date Received
    July 8, 2008
    Date of Event
    January 1, 2006
    Report Date
    June 26, 2008
    Manufacturer
    BARD LIFE SCIENCES
    Product Code
    MAF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PRODUCT IMPLANTED WHEN MISLABELED BY MANUFACTURER. PRODUCT WAS 100 CM - BOX STATED (LABELED) 150 CM. CAUSED MD - OPERATOR TO INSERT LONGER STENT RECEIVED SECOND DEVICE. RESULTING IN DISCARD OF SHORT STENT OPENED AND DEPLOYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARD LIFESCIENCE (BARD) LIFE STENT MAF BARD LIFE SCIENCES SX061503CD 58494455

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR