InjuryMLO
PHILIPS EXTENDED HOLTER EPATCH FLEX ADAPTER
Received Apr 29, 2025 · Event occurred Apr 19, 2025
Report MW5169622 · MDR key 21927118
Device
Generic name
Electrocardiograph, Ambulatory, With Analysis Algorithm
Manufacturer
Philips North America LlcProduct problems
- Patient-Device Incompatibility
Patient
42 YR · Female
- Foreign Body Reaction
- Itching Sensation
- Peeling
- Burning Sensation
- Blister
- Skin Inflammation/ Irritation
- Foreign Body Reaction
- Itching Sensation
- Peeling
- Burning Sensation
- Blister
- Skin Inflammation/ Irritation
Narrative
Description of Event or Problem
I WAS PRESCRIBED A PHILIPS HOLTER MONITOR PATCH TO WEAR FOR 7 DAYS. AFTER 3.5 DAYS, MY SKIN WAS SO IRRITATED AND ITCHY IN THE LOCATION OF THE ELECTRODE. THE ELECTRODE CREATED A BURNING SENSATION WHEN APPLIED, AND I STOPPED USING THE DEVICE PREMATURELY. IT IS NOW 3 DAYS LATER, AND MY SKIN IS BLISTERED AND PEELING. THE AREA IS VERY RED AND RAW.