BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALGREENS

    MDR report key: 16405023 · Received February 20, 2023

    Report

    Report Number
    1832894-2023-00002
    Event Type
    Injury
    Date Received
    February 20, 2023
    Date of Event
    January 30, 2023
    Report Date
    February 16, 2023
    Manufacturer
    LIVING SCIENCE CO., LTD.
    Product Code
    DXN
    UDI-DI
    00311917183404
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT CLAIMED THAT THEY STOPPED TAKING THEIR "BLOOD PRESSURE MEDICINE" BASED ON READINGS FROM THE DEVICE. THIS IS DIRECT CONFLICT WITH TWO (2) OF THE FIRST THREE (3) WARNINGS ON PAGE 4 OF THE INSTRUCTIONS FOR USE: "PLEASE NOTE THAT THIS IS A HOME HEALTHCARE PRODUCT ONLY AND IT IS NOT INTENDED TO SERVE AS A SUBSTITUTE FOR THE ADVICE OF A PHYSICIAN OR MEDICAL PROFESSIONAL." "DO NOT USE THIS DEVICE FOR DIAGNOSIS OR TREATMENT OF ANY HEALTH PROBLEM OR DISEASE. MEASUREMENT RESULTS ARE FOR REFERENCE ONLY. CONSULT A HEALTHCARE PROFESSIONAL FOR INTERPRETATION OF PRESSURE MEASUREMENTS. CONTACT YOUR PHYSICIAN IF YOU HAVE OR SUSPECT ANY MEDICAL PROBLEM. DO NOT CHANGE YOUR MEDICATIONS WITHOUT THE ADVICE OF YOUR PHYSICIAN OR HEALTHCARE PROFESSIONAL."

    Description of Event or Problem · 0

    HOMEDICS RECEVIED MDR REPORT # MW5114567 ON 2/7/2023. IN THE REPORT THE INDIVIDUAL WHO MADE THE REPORT AND WANTED TO REMAIN CONFIDENTIAL CLAIMED THE FOLLOWING: "THIS MACHINE GIVES ME LOW READINGS AND THEREFORE, I HAVE NOT TAKEN MY BLOOD PRESSURE MEDICATION IN WEEKS, AND I HAVE BEEN HAVING HEADACHES AND PRESSURE IN MY EYESIGHT." THE ALLEGED THIS WAS WITH MODEL #: WGNBPA-950. NOTE: THE INDIVIDUAL REPORTED THE MANUFACTUER AS "HOMEDICS GROUP CANADA". THIS IS NOT CONSISTENT AS THE MODEL IDENTIFIED (WGNBPA-950) IS SOLD EXCLUSIVELY TO WALGREENS IN THE US UNDER THEIR PRIVATE LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1319495 WALGREENS DELUXE ARM BLOOD PRESSURE MONITOR DXN LIVING SCIENCE CO., LTD. WGNBPA-950 UNKNOWN 00311917183404

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other