BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WITHINGS BPM CONNECT

    MDR report key: 16225616 · Received January 20, 2023

    Report

    Report Number
    MW5114424
    Event Type
    Malfunction
    Date Received
    January 20, 2023
    Date of Event
    January 13, 2023
    Report Date
    January 18, 2023
    Manufacturer
    WITHINGS
    Product Code
    DXN
    UDI-DI
    03700546705984
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAD BEEN USING A WITHINGS BPM CONNECT BLOOD PRESSURE CUFF. IT WAS READING HIGH WHICH WE DID NOT REALIZE UNTIL I COMPARED IT WITH THE DOCTOR'S OFFICE BLOOD PRESSURE READING. THIS RESULTED IN ME TAKING A BLOOD PRESSURE MEDICATION FOR SEVERAL MONTHS WHEN I DID NOT REQUIRE ONE. OTHER THAN TAKING A MEDICATION I DIDN'T NEED, NO INJURY WAS SUSTAINED. I REPORTED TO WITHINGS AND HAVE HAD SEVERAL EMAILS BACK AND FORTH WITHOUT A SATISFACTORY RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1348226 WITHINGS BPM CONNECT SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE DXN WITHINGS WPM05 03700546705984

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Other EMGALITY | FISH OIL | FLEXERIL | GABAPENTIN | L-METHYLFOLATE| SYNTHROID | TRAMADOL | TYLENOL | VORTIOXETINE