BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMRON

    MDR report key: 119569 · Received September 12, 1997

    Report

    Report Number
    1450057-1997-00001
    Event Type
    Injury
    Date Received
    September 12, 1997
    Date of Event
    August 11, 1997
    Report Date
    September 10, 1997
    Manufacturer
    MARS MEDICAL PROD.
    Product Code
    DXN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFO RECEIVED FROM MFR ON 02/27/1998: CO HAS COMPLETED THEIR INVESTIGATION OF THIS REPORT. UPON EXAMINATION OF THE MEDICAL RECEIPTS/RECORDS PROVIDED, THERE WAS NO INDICATION OR MENTION OF EAR CANAL INJURY/DAMAGES DONE TO THIS INDIVIDUAL. BASED UPON THIS INFO CO'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMRON SELF TAKING BLOOD PRESSURE KIT DXN MARS MEDICAL PROD. HEM 18S 412909

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention