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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THERMOGRAPHY; SYSTEM, TELETHERMOGRAPHIC (ADJUNCTIVE USE)
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THERMOGRAPHY; SYSTEM, TELETHERMOGRAPHIC (ADJUNCTIVE USE) Back to Search Results
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Cancer (3262)
Date of Event 01/11/2019
Type of Reportable Event Serious Injury
Event or Problem Description
I had a self detected lump in my breast despite a thermography in september before telling me i had low risk of cancer.On january 11, in the morning i had a thermography and even pointed to the lump.The report came back that i had a low risk of any cancer.Luckily that afternoon i had a diagnostic mammogram, then a sonogram.A couple days later, i had a needle biopsy that proved invasive breast cancer.I urge fda to make thermography illegal.All my drs at (b)(6) center and (b)(6) clinic told me they wanted it off the market and we would save many breasts and also many women.The costs of late care is much higher as well.I have copies of both tests and would be willing to discuss.I am convinced that i would not have had to lose lymph nodes and radiation treatment if i had not been told that thermography was fda approved for breast cancer detection.Fda safety report id# (b)(4).
 
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Brand Name
THERMOGRAPHY
Common Device Name
SYSTEM, TELETHERMOGRAPHIC (ADJUNCTIVE USE)
MDR Report Key8866504
Report NumberMW5088846
Device Sequence Number2885354
Product Code LHQ
Combination Product (Y/N)N
Initial Reporter StateVA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Voluntary
Initial Reporter Occupation Patient
Type of Report Initial
Report Date (Section B) 08/04/2019
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
Operator of Device No Information
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date08/05/2019
Patient Sequence Number1
Outcome Attributed to Adverse Event Life Threatening; Required Intervention;
Patient Age69 YR
Patient Weight63
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