BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRO -14 "S" NEURO GUIDEWIRE

    MDR report key: 673126 · Received February 3, 2006

    Report

    Report Number
    6000078-2006-00025
    Event Type
    Malfunction
    Date Received
    February 3, 2006
    Date of Event
    January 5, 2006
    Report Date
    February 2, 2006
    Manufacturer
    PRECISION VASCULAR, A DIVISION OF BOSTON SCIENTIFIC
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CORP BECAME AWARE OF AN EVENT IN WHICH WHEN THE PACKAGE OF THE SUBJECT DEVICE WAS OPENED, A HAIR WAS FOUND SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRO -14 "S" NEURO GUIDEWIRE GUIDEWIRE DQX PRECISION VASCULAR, A DIVISION OF BOSTON SCIENTIFIC * B03958

    Patients

    Seq Age Sex Outcome Treatment
    1 *