ePatch 900-0632-00Recalls & reported problems

Braemar Manufacturing, LLC · ePatch Holter Device · Class 2

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B146EP020), received between Apr 24, 2023 and Apr 24, 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

Device problems

Biocompatibility1
Patient-Device Incompatibility1

Patient problems

Blister1
Skin Inflammation/ Irritation1

Recent adverse event reports

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

InjuryApr 24, 2023Patient-Device Incompatibility; Biocompatibility; Patient-Device Incompatibility; Biocompatibility
THE PATIENT CALLED STATING PATCH HAS CAUSED REACTION - SORE PAINFUL PEELING SKIN. NOTICED SINCE DAY 1. THE PATIENT'S SKIN WAS PREPPED WITH ALCOHOL AND PATCH REPLACED DAILY . NEOSPORIN CREAM WAS USED ON SKIN. THE PATIENT IS STILL CURRENTLY WEARING DEVICE . SKIN SENSITIVITY KNOWN PRIOR TO RECEIVING DEVICE. PATIENT SERVICES CALLED THE PATIENT 3 TIMES OBTAIN ADDITIONAL INFORMATION AND NO ANSWER. ADDITIONAL INFORMATION WAS PROVIDED ON 12 APRIL 2023 FROM PATIENT SERVICES FROM THE PATIENT: THE PATIENT REPORTED THAT THEY WERE PRESCRIBED HYDROCORTISONE CREAM BY THEIR DOCTOR. THE PATIENT COULD NOT RECALL THE NAME OF BRAND THAT WAS PRESCRIBED.
Patient problems: Blister; Skin Inflammation/ Irritation
MAUDE report 16794976 ↗

Device details

UDI-DI	`B146EP020`
Brand	ePatch
Model	900-0632-00
Company	Braemar Manufacturing, LLC
Product code	DSH · Recorder, Magnetic Tape, Medical
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 25, 2026

Device type (GMDN): Electrocardiographic ambulatory recorder

An electrically-powered, noninvasive device designed to be worn by a patient during daily activities for 24-hour recording of the electrocardiographic signals of the heart, for the diagnosis of cardiac disorders (e.g., arrhythmias). The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer with a dedicated software. Otherwise known as a Holter monitor, the device typically incorporates display and controls, and may include surface electrodes, lead wires and accessories intended for attachment/removal (e.g., wipes, adhesive remover).

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.