InjuryKGX
Vivalink ECG Adhesive
Received Jul 27, 2026 · Event occurred Apr 14, 2025
Report 3011651603-2026-00008 · MDR key 50002600
Device
Product problems
- Patient-Device Incompatibility
Patient
Male
- Skin Inflammation/ Irritation
Narrative
Description of Event or Problem
The participant reported he had a mark/skin reaction after wearing the Vivalink sensor with adhesive. From the complaint description, the user experienced skin redness and pain when peeled off the adhesive for 8-14 days wearing. While the recommended wearing duration of A13 is 4 days. Overwearing outside the IFU specified duration, is known factor to increase the likelihood of skin reaction.
Additional Manufacturer Narrative
Retrospective record review and proactive reporting of incidents where available information is insufficient to confirm non-seriousness.