BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWTRON

    MDR report key: 186530 · Received September 3, 1998

    Report

    Report Number
    MW4002328
    Event Type
    Malfunction
    Date Received
    September 3, 1998
    Date of Event
    September 1, 1998
    Report Date
    September 3, 1998
    Manufacturer
    HUNTLEIGH HEALTHCARE, INC.
    Product Code
    JOW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MOISTURE IS PRESENT INSIDE OF THE TUBES WITHIN THE STERILE PACKAGING - CANNOT USE AS A STERILE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOWTRON PROPHYLACTIC D.V.T. SYSTEM JOW HUNTLEIGH HEALTHCARE, INC. * M990001 4/93

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other