BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPUTERIZED BLOOD PRESSURE MACHINE

    MDR report key: 92567 · Received May 22, 1997

    Report

    Report Number
    MW4001878
    Event Type
    Injury
    Date Received
    May 22, 1997
    Report Date
    May 1, 1997
    Manufacturer
    COMPUTERIZED SCREENING, INC.
    Product Code
    DSK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT TRIED TO USE A BLOOD PRESSURE MACHINE AT A PHARMACY. THE DEVICE CONSTRICTED, BUT HE FELT IT OVER CONSTRICTED. HIS ARM WAS PINCHED AND BRUISED. HE SAID HE FELT TINGLING IN HIS FINGERS WHEN THE DEVICE TIGHTENED. THE BRUISE LASTED THREE DAYS. THE MACHINE SAID IT COULD NOT GIVE HIM A READING. INVESTIGATOR VISITED THE PHARMACY AND SPOKE TO THE STORE MGR, AND THE PHARMACY MGR. NEITHER WERE AWARE OF ANY COMPLAINTS OF APPX. 2 WKS AGO TO REPAIR THE COMPUTER DISPLAY. THE DEVICE IS NOT APPROPRIATELY LABELED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPUTERIZED BLOOD PRESSURE MACHINE COMPUTERIZED BLOOD PRESSURE MACHINE DSK COMPUTERIZED SCREENING, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *