BEUDAMED
    FDA Adverse Event Other Summary report: N

    ATRION DISPOSABLE INFLATION DEVICE AQL 1015

    MDR report key: 539570 · Received August 18, 2004

    Report

    Report Number
    539570
    Event Type
    Other
    Date Received
    August 18, 2004
    Date of Event
    September 1, 2003
    Report Date
    September 1, 2003
    Manufacturer
    ATRION MEDICAL PRODUCTS
    Product Code
    MAV
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BALLOON FAILED TO INFLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATRION DISPOSABLE INFLATION DEVICE AQL 1015 CATHETER BALLOON MAV ATRION MEDICAL PRODUCTS QL1015 AM040402-1

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other