BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WITHINGS BPM CONNECT BLOOD PRESSURE MONITOR

    MDR report key: 17254190 · Received July 3, 2023

    Report

    Report Number
    MW5119091
    Event Type
    Injury
    Date Received
    July 3, 2023
    Date of Event
    June 29, 2023
    Report Date
    June 29, 2023
    Manufacturer
    WITHINGS
    Product Code
    DXN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    HELLO, MY WIFE IS AT HIGH RISK FOR PRE-ECLAMPSIA WE PURCHASED A WITHINGS CONNECT BLOOD PRESSURE MONITOR. THE DEVICE IS WIDELY COMPLAINED ABOUT ONLINE BY CONSUMERS TO GIVE INACCURATE HIGH BLOOD PRESSURE READINGS. WE WERE NOT AWARE OF THIS WHEN WE PURCHASED IT. WE SENT MULTIPLE VIDEOS TO WITHINGS SUPPORT CONFIRMING THE INACCURATE READINGS, HOWEVER THEY REFUSE TO ADMIT IT IS FAULTY. MY WIFE WAS TOLD BY HER DOCTOR SEVERAL TIMES TO GO TO THE ER DURING PREGNANCY TO CHECK FOR PREECLAMPSIA DUE TO THE FAULTY READINGS OF THIS DEVICE. SHE'S BEEN UNDER STRESS DUE TO THIS DEVICE MAKING HER BELIEVE SHE COULD HAVE PREECLAMPSIA AGAIN. WITHINGS NEEDS TO HAVE THIS DEVICE RECALLED AND FDA APPROVAL NEEDS TO BE REVOKED. ACTUAL BLOOD PRESSURE WAS 120/80 (ER(EMERGENCY ROOM)) DEVICE IS REPORTING 160/100.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497690 WITHINGS BPM CONNECT BLOOD PRESSURE MONITOR SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE DXN WITHINGS

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Hospitalization