BEUDAMED
    FDA Adverse Event Other Summary report: N

    BREG

    MDR report key: 746411 · Received October 7, 2005

    Report

    Report Number
    MW1036891
    Event Type
    Other
    Date Received
    October 7, 2005
    Date of Event
    October 3, 2005
    Report Date
    October 7, 2005
    Manufacturer
    BREG, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TUBING LEAKS AT CONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREG POLAR PUMP FRN BREG, INC. 012005 25215160

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other