BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLE WATCH ALUMINUM 41MM

    MDR report key: 18536893 · Received January 17, 2024

    Report

    Report Number
    MW5150495
    Event Type
    Injury
    Date Received
    January 17, 2024
    Date of Event
    August 15, 2023
    Report Date
    January 13, 2024
    Manufacturer
    APPLE INC.
    Product Code
    QDA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IN AUGUST, I NOTICED I DEVELOPED A RASH SEVERE RASH AFTER WEARING MY APPLE WATCH. THE RASH IS VERY RED AND THE SKIN ALMOST APPEARS BURNED. IT TAKES 2-3 WEEKS TO HEAL FROM THE RASH. I AM AN EPIDEMIOLOGIST AND HAVE WORN APPLE WATCHES FOR NEARLY 10 YEARS WITHOUT ISSUE. THIS PARTICULAR WATCH I HAVE BEEN WEARING FOR ABOUT 2 YEARS. I CLEANED THE WATCH AND LET THE RASH HEAL. I TRIED TO WEAR THE WATCH AGAIN AND DEVELOPED A NEW RASH. I REPEATED THE STEPS AND TRIED AGAIN, DEVELOPING A THIRD RASH. I NOTICED ON THE BACK OF THE WATCH THERE APPEARS TO BE AN IMPERFECTIONS AROUND THE BATTERY IN THE AREA THE RASH WAS DEVELOPING. MY SISTER-IN-LAW TRIED WEARING THE WATCH AND DEVELOPED REDNESS AND IRRITATION WITHIN 39 MIN OF WEAR. I TOOK THE WATCH INTO THE APPLE STORE AND SHOWED THEM THE RASH. THEY INTERVIEWED ME AND SAID THEY WOULD REPLACE THE WATCH. 2 WEEKS LATER THEY RETURNED THE DEFECTIVE DEVICE TO ME AND TOLD ME TO CALL APPLE. AFTER CALLING APPLE AND DESCRIBING THE SITUATION, THEIR SAFETY TEAM ASKED ME TO PUT THE WATCH BACK ON IN ORDER TO TAKE PICTURES OF THE RASH AND GO TO A DOCTOR BEFORE THEY WOULD REPLACE THE WATCH. SAYING IF I DIDN'T COMPLY THEY WOULD NOT DO ANYTHING FOR ME (CREATING AN ULTIMATUM). THIS LED TO ME DEVELOPING TWO ADDITIONAL RASHES, ONE WHICH IS STILL HEALING AFTER 6 WEEKS. I AM PREGNANT AND UNABLE TO TAKE ANY STEROID TREATMENT FOR THE RASH. THIS IS SOMETHING I EXPLAINED TO THE SAFETY TEAM. APPLE NEVER REQUESTED TO HAVE THE WATCH TO TEST IT FOR ISSUES OR LEAKING BATTERY ACID OR ANYTHING. I WORK IN A PHARMACEUTICAL COMPANY AND AM HONESTLY SHOCKED AT HOW WILLING THIS COMPANY IS TO CAUSE HARM AND DAMAGE TO PEOPLE USING THEIR DEVICE. EVEN IF THEY FEEL THEY ARE NOT AT FAULT BECAUSE THEY FEEL IT IS AN ALLERGY. IF THIS WERE A DRUG, A PHARMACEUTICAL COMPANY WOULD NEVER ASK YOU TO TAKE THE MEDICATION TO REDEVELOP THE REACTION FOR THEM. I AM NOT A TEST ANIMAL, I AM A HUMAN BEING. THEIR APPROACH SEEMS TO BE TO INCREASE THE HARM AND DAMAGE A PERSON EXPERIENCES WHO IS HAVING A ADVERSE REACTION IN ORDER TO AVOID REPLACING THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2065339 APPLE WATCH ALUMINUM 41MM ELECTROCARDIOGRAPH SOFTWARE FOR OVER-THE-COUNTER USE QDA APPLE INC. MNU93LL/A

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Required Intervention BABY ASPIRIN| MAGNESIUM| PRENATAL