BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOMEDICS

    MDR report key: 876645 · Received June 11, 2007

    Report

    Report Number
    1832894-2007-00061
    Event Type
    Other
    Date Received
    June 11, 2007
    Date of Event
    February 15, 2007
    Report Date
    April 3, 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

    RETURN AUTHORIZATION ISSUED 04/04/2007 AND REPLACEMENT SENT TO CONSUMER. NO FURTHER INFO AVAILABLE.

    Description of Event or Problem · 1

    DUE TO HIGH READING DR INCREASED BP MEDICATION. ON SECOND HIGH READING, CONSUMER TOOK BP MONITOR TO DR'S OFFICE WHERE IT WAS FOUND THAT IT WAS READING TOO HIGH. NO INJURY TO CONSUMER. SHE IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMEDICS BLOOD PRESSURE MONITOR DXN ROSSMAX INTERNATIONAL LTD. BPA-150 3126202119

    Patients

    Seq Age Sex Outcome Treatment
    1 YR