BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SGW STABLIZER .014 300CM J SS

    MDR report key: 787674 · Received November 16, 2006

    Report

    Report Number
    1016427-2006-00113
    Event Type
    Malfunction
    Date Received
    November 16, 2006
    Date of Event
    October 17, 2006
    Report Date
    November 16, 2006
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN REMOVING THE WIRE FROM THE PROTECTIVE COIL THE TIP OF THE WIRE APPEARED TO BE KINKED AND SEPARATED. THE PRODUCT WAS NOT USED IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SGW STABLIZER .014 300CM J SS CARDIOLOGY WIRES & METALS DQX CORDIS CORPORATION NA 70706728

    Patients

    Seq Age Sex Outcome Treatment
    1 NA