BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHINOBI SGW

    MDR report key: 481949 · Received September 5, 2003

    Report

    Report Number
    1016427-2003-00166
    Event Type
    Injury
    Date Received
    September 5, 2003
    Date of Event
    August 9, 2003
    Report Date
    September 5, 2003
    Manufacturer
    CORDIS CORP. (MIAMI)
    Product Code
    DQX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE GUIDEWIRE FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHINOBI SGW CARDIOLOGY WIRES & METALS DQX CORDIS CORP. (MIAMI) NA A0901958

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention