BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOMEDICS

    MDR report key: 883057 · Received July 19, 2007

    Report

    Report Number
    9680548-2007-00003
    Event Type
    Other
    Date Received
    July 19, 2007
    Date of Event
    June 13, 2007
    Report Date
    July 4, 2007
    Manufacturer
    ROSSMAX INTERNATIONAL LTD.
    Product Code
    DXN
    PMA / PMN Number
    K013539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO RETURNED UNIT FOR EVALUATION. ADDITIONAL MODEL # BPA-200.

    Description of Event or Problem · 1

    ACCORDING TO HOMEDICS, INC. MDR NO. 1832894-2007-00063 STATING, "CONSUMER TOOK TWO UNITS TO THE DOCTOR IN 2007. BOTH UNITS READ HIGH COMPARED TO THE DOCTOR'S READING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMEDICS BLOOD PRESSURE MONITOR DXN ROSSMAX INTERNATIONAL LTD. BPA-250

    Patients

    Seq Age Sex Outcome Treatment
    1 YR