Epatch 2.0 02-01575Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B146EP2010), received between Apr 25, 2023 and Apr 25, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Biocompatibility” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 25, 2023Patient-Device Incompatibility; Biocompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Biocompatibility; Patient Device Interaction Problem

  THE PATIENT REPORTED ON (B)(6) 2023 THAT ON (B)(6)THEY REMOVED DUE TO THE MALFUNCTION. THE PATIENT TOOK OFF THE PATCH BECAUSE THEIR CHEST WAS BURNING AND FELT EXTREMELY ITCHY AND THAT'S WHEN THE PATIENT SAW THE PATCH WAS COVERED IN BROWN GOO AND THEIR SKIN WAS BLISTERED AND RED ALL OVER WHERE THE EPATCH MONITOR WAS SITTING. THE PATIENT WENT TO THE EMERGENCY ROOM AND SHOWED THEM HER CHEST AND BREAST AND WAS TOLD IT WAS A REACTION TO THE BATTERY ACID. THE PATIENT WAS PRESCRIBED TRIAMCINOLONE 0.5 % OINTMENT BECAUSE OF HOW SEVERE THE ALLERGIC REACTION WAS. THE PATIENT ALSO HAD TO USE SCAR CREAM FOR HER CHEST BECAUSE OF BAD THE BATTERY SCARED HER CHEST. THE PATIENT IS NO LONGER ON SERVICE AND HAS RETURNED THE KIT AND DOES NOT HAVE A HISTORY OF SKIN SENSITIVITIES. THE PATCH LOT NUMBER IS UNKNOWN AS THE KIT HAS BEEN RETURNED.

  Patient problems: Blister; Burning Sensation; Skin Inflammation/ Irritation

  MAUDE report 16809191 ↗