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

Model Number	MG133LL/A
Health Effect - Clinical Codes	Erythema (1840); Peeling (1999)
Date of Event	04/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
I experienced a thermal injury while wearing my apple watch.I was wearing it during a workout and throughout the day.When i went to charge it at night, i noticed redness and tenderness at the area on my wrist where the watch touches my skin.The skin was red and peeled off like a sunburn.I have several photos and plan to see a doctor.

• Brand Name: APPLE WATCH
• Common Device Name: ELECTROCARDIOGRAPH SOFTWARE FOR OVER-THE-COUNTER USE
• Manufacturer (Section D): APPLE INC.
• MDR Report Key: 25047202
• Report Number: MW5187513
• Device Sequence Number: 20131741
• Product Code: QDA
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 04/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MG133LL/A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2026
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Race: White