BEUDAMED
    FDA Adverse Event Death Summary report: N

    HYPERGLIDE OCCLUSION BALLOON CATHETER

    MDR report key: 489807 · Received October 17, 2003

    Report

    Report Number
    2029214-2003-00040
    Event Type
    Death
    Date Received
    October 17, 2003
    Date of Event
    September 13, 2003
    Report Date
    September 16, 2003
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    MJN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    VERBAL REPORT OF PT EVENT AND SUBSEQUENT DEATH IN CASE USING BALLOON CATHETER. NO DETAILS YET PROVIDED. NO INDICATION OF PRODUCT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYPERGLIDE OCCLUSION BALLOON CATHETER OCCLUSION BALLOON CATHETER MJN MICRO THERAPEUTICS, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death