SAMSUNG GALAXY5
Received Dec 22, 2022 · Event occurred Dec 14, 2022
Report MW5113980 · MDR key 16043463
Device
Generic name
Electrocardiograph Software For Over-the-counter Use
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
80 YR · Female
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
ON (B)(6) 2022 I PURCHASED A SAMSUNG GALAXY WATCH 5 BUT DID NOT START WEARING IT UNTIL RECENTLY. IT WAS NECESSARY TO WEAR THIS CLOSE TO/NEXT TO YOUR SKIN ON YOUR WRIST IN ORDER TO RECORD HEART RATE, EKG, PULSE O², ETC. I STARTED WEARING IT MORE REGULARLY IN THE PAST WEEK. ON WEDNESDAY (B)(6) 2022 I NOTICED WHEN REMOVED THE WATCH, A "LUMP" HAD FORMED ON MY WRIST DIRECTLY UNDER THE WATCH SENSOR. THIS IS NOT AN IRRITATION, RASH, ABRASION OR OTHER. IT IS SUBCUTANEOUS ROUND SOMEWHAT FIRM, UNATTACHED, NONPAINFUL MASS (RESEMBLING A LIPOMA) THE EXACT SIZE AS THE RING ON THE UNDERSIDE OF THE WATCH. AFTER 5 DAYS OF NOT WEARING, THE LUMP IS APPARENTLY UNCHANGED. I HAVE NOTHING LIKE THIS ANYWHERE ELSE AND AM NOT PRONE TO SUCH. I AM 80, A RETIRED NURSE, WEIGHING 118 LBS. I WOULD WELCOME YOUR INPUT. IF THIS IS NOT THE CORRECT FORM OR AGENCY, PLEASE REDIRECT AS FINDING HELP OR INFORMATION WAS QUITE DIFFICULT. I DID RETURN THE WATCH WHICH WAS $259.00. NO TESTS WERE PERFORMED AS I AM JUST NOW INFORMING MY PHYSICIAN WHO I SUSPECT WILL ORDER NOTHING. HE IS ASSOCIATED WITH A HOSPITAL THAT REWARDS THEIR PHYSICIANS MONETARILY FOR SAVING MONEY BY NOT ORDERING TESTS. WE SHALL SEE.