BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPACT WRISTS BLOOD PRESSURE MONITOR

    MDR report key: 220656 · Received April 23, 1999

    Report

    Report Number
    1450057-1999-00002
    Event Type
    Injury
    Date Received
    April 23, 1999
    Date of Event
    January 1, 1999
    Report Date
    April 13, 1999
    Manufacturer
    OMRON HEALTHCARE, INC.
    Product Code
    DXN
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    DEVICE USED BY CONSUMER FOR 3 DAYS. DURING EVENING AFTER THIRD USE, CONSUMER CLAIMS TO HAVE EXPERIENCED PAIN, SWELLING, BRUSING IN BOTH WRISTS. CONSUMER WAITED 9 DAYS BEFORE SEEING DOCTOR. DOCTOR REFERRED HER TO A SPECIALIST. CONSUMER WILL NOT PERMIT OHI TO EXAMINE SUSPECT DEVICE. CONSUMER WILL NOT PERMIT RELEASE OF DOCTOR RECORD OF PATIENT EXAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPACT WRISTS BLOOD PRESSURE MONITOR BLOOD PRESSURE MONITOR DXN OMRON HEALTHCARE, INC. HEM-605 811

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention