BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOMEDICS

    MDR report key: 876642 · Received June 11, 2007

    Report

    Report Number
    1832894-2007-00064
    Event Type
    Other
    Date Received
    June 11, 2007
    Date of Event
    January 6, 2007
    Report Date
    April 27, 2007
    Manufacturer
    ROSSMAX INTERNATIONAL LTD.
    Product Code
    DXN
    PMA / PMN Number
    K013539
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONSUMER HAS NOT RETURNED THE UNIT FOR EVAL.

    Description of Event or Problem · 1

    BP MONITOR READING HIGH. CONSUMER TOOK BLOOD PRESSURE MEDICATION DUE TO HIGH READING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMEDICS BLOOD PRESSURE MONITOR DXN ROSSMAX INTERNATIONAL LTD. BPA-150

    Patients

    Seq Age Sex Outcome Treatment
    1 YR