ePatch 2.0 BTI 02-01650Recalls & reported problems
Braemar Manufacturing, LLC · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI B146EP2020), received between Jun 1, 2023 and Jun 1, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Excessive Heating” (2 reports).
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
- Excessive Heating2
- Overheating of Device2
- Temperature Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 1, 2023Overheating of Device; Temperature Problem; Excessive Heating; Overheating of Device; Temperature Problem; Excessive Heating
IT WAS REPORTED THAT THE DEVICE WAS HOT TO THE TOUCH AND THE BATTERY WAS SWELLING/BUDGING WITH VISIBLE CRACKS. THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY, OR IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17043831 ↗MalfunctionJun 1, 2023Overheating of Device; Temperature Problem; Excessive Heating; Overheating of Device; Temperature Problem; Excessive Heating
IT WAS REPORTED THAT THE DEVICE WAS HOT TO THE TOUCH AND THE BATTERY WAS SWELLING/BUDGING WITH VISIBLE CRACKS. THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY, OR IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17043743 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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