MAUDE Adverse Event Report: APPLE INC. APPLE WATCH ALUMINUM 41MM; ELECTROCARDIOGRAPH SOFTWARE FOR OVER-THE-COUNTER USE

Model Number	MNU93LL/A
Health Effect - Clinical Codes	Erythema (1840); Hypersensitivity/Allergic reaction (1907); Rash (2033); Skin Inflammation/ Irritation (4545)
Date of Event	08/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
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.

• Brand Name: APPLE WATCH ALUMINUM 41MM
• Common Device Name: ELECTROCARDIOGRAPH SOFTWARE FOR OVER-THE-COUNTER USE
• Manufacturer (Section D): APPLE INC.
• MDR Report Key: 18536893
• Report Number: MW5150495
• Device Sequence Number: 20060426
• Product Code: QDA
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 01/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MNU93LL/A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2024
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BABY ASPIRIN; MAGNESIUM; PRENATAL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White, American Indian Or Alaskan Native