MAUDE Adverse Event Report: THERMAL IMAGING; SYSTEM, TELETHERMOGRAPHIC (ADJUNCTIVE USE)

Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Date of Event	03/18/2024
Type of Reportable Event	Death
Event or Problem Description
Thermal imaging / functional infrared device misuse - my wife's providers represented thermal imaging as an alternative that they could identify breast cancer with their thermal imaging use and did not advise that thermal imaging is only an adjunctive method.Website ((b)(6) is the owner - (b)(6)) states "welcome to (b)(6) leading healthcare imaging service.We specialize in an innovative, safe alternative to conventional body imaging and health screenings.Our personal and professional services provide diverse body imaging choices for men, women, and children; a full body scan, a partial body scan or breast imaging.Thermography is a reliable method to detect the signs of health conditions before they become a problem allowing you to make changes that will help your body heal." report from (b)(6) 2024, visit showed she was at risk of developing aggressive tissue, but did not indicate she had any aggressive tissue.No referral was made.I have significant documentation.On the reports, the "reader" is (b)(6).He consulted with my wife on the imaging run by (b)(6).I found out after the fact that he was previously warned in conjunction with (b)(6) in 2019 by the fda about their misuse of thermal imaging.(b)(6) were the subject of abc's good morning america, nightline, and online articles for their misuse of thermal imaging.(b)(6) doctor of chiropractic license was pulled by state of (b)(6) in 2023 because of his violations.He still kept the (b)(6) initials on the reports provided to my wife in 2024.He also represented himself as a functional medicine doctor and (b)(6), he, and his other colleagues all refer to him as "doctor" in their communications to my wife.We became especially aware of their incompetence after a follow-up scan for (b)(6) 2024, showed massive changes to the breast and (b)(6) recommended following up in another year.Pdfs of reports can be provided.Horrific misdirection and minimization of symptoms provided.Breast cancer metastasized because of this and killed her on (b)(6) 2024.

• Brand Name: THERMAL IMAGING
• Common Device Name: SYSTEM, TELETHERMOGRAPHIC (ADJUNCTIVE USE)
• MDR Report Key: 22467526
• Report Number: MW5172494
• Device Sequence Number: 8225360
• Product Code: LHQ
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 07/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/10/2025
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability; Hospitalization; Death
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White