BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WITHINGS PULSEHR (NEW)

    MDR report key: 13118295 · Received December 29, 2021

    Report

    Report Number
    MW5106373
    Event Type
    Injury
    Date Received
    December 29, 2021
    Date of Event
    November 3, 2021
    Report Date
    December 27, 2021
    Manufacturer
    WITHINGS S.A.
    Product Code
    DQA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PURCHASED WITHINGS HEALTH FITNESS TRACKER PULSEHR AND STARTED WEARING THE TRACKER. AFTER 6 MONTHS OF WEARING START FEELING IRRITATION ON WRIST WHERE THE TRACKER WAS WORN AND DISAPPEARED IN FEW DAYS- FIGURED MIGHT BE JUST MY THINKING- WASHED WITH WATER THROUGHLY AND STARTED WEARING AGAIN- AFTER A 3-4 WEEKS OF TIME I START HAVING SAME IRRITATION SKIN ISSUE- I WAS CLEANING TRACKER PERIODICALLY. I STARTED SEEING SOME BURN MARKS ON MY SKIN WITH BLOOD COMING OUT. I TOOK TRACKER AND WORE ON OTHER HAND JUST TO MAKE SURE. I STARTED FEELING THE SAME WAY AT OTHER HAND. I WAS SURE THAT THERE IS SOME TYPE OF RADIATION HAPPENING. I TOOK WATCH OUT AND SEND THE EMAIL TO WITHINGS AND REQUESTED INVESTIGATION ON IT. I ALSO SEND THEM PICTURES OF MY WRIST. THEY REPLY THAT ITS MOST LIKELY CLEANING ISSUE AND WE DON'T HAVE CASES LIKE THAT. I TOLD THEM MY HAND IS BURNT AND I AM CLEANING THIS TRACKER REGULARLY. AT THE END THEY OFFER ME REFUND. THEY DON'T THINK IT'S IMPORTANT FOR THEM TO PUT SOME EFFORT ON IT AND FIND OUT THERE MIGHT BE ISSUE WITH THERE TRACKER. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2014011 WITHINGS PULSEHR (NEW) OXIMETER DQA WITHINGS S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male Required Intervention