BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMMODORE

    MDR report key: 384066 · Received March 20, 2002

    Report

    Report Number
    1058196-2002-00006
    Event Type
    Malfunction
    Date Received
    March 20, 2002
    Date of Event
    February 6, 2002
    Report Date
    March 20, 2002
    Manufacturer
    CORDIS NEUROVASCULAR
    Product Code
    DQT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE BALLOON DID NOT INFLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMMODORE CES BALLOON CATHETER DQT CORDIS NEUROVASCULAR NA D1201112

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN