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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cancer (3262)

Event Date 01/11/2019

Event Type  Injury  

Event 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).

• Brand Name: THERMOGRAPHY
• Type of Device: SYSTEM, TELETHERMOGRAPHIC (ADJUNCTIVE USE)
• MDR Report Key: 8866504
• MDR Text Key: 153701993
• Report Number: MW5088846
• Device Sequence Number: 1
• Product Code: LHQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 63