Mcot Patch 390-0131-02Recalls & reported problems
Braemar Manufacturing, LLC · 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 B146MCP0), received between Jan 3, 2020 and Jan 3, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information1
- Patient Device Interaction Problem1
Patient problems
- Burn(s)1
- Skin Irritation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 3, 2020Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem
THE PATIENT PRESENTED TO THEIR HEALTHCARE PROVIDER WITH A SKIN BURN FROM DEVICE USAGE. PATIENT REPORTED SEEKING MEDICAL ATTENTION FOR STAPH INFECTION.
Patient problems: Burn(s); Skin Irritation
MAUDE report 9548408 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.