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

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 11/15/2021

Event Type  malfunction  

Event Description

(b)(6) dr (b)(6) continues to use thermography to "screen" for cancer on my mother.(b)(6).(b)(6) is a quack.Shut her down.Which (b)(6) missed.And likely contributed to her having cancer due to the stem cell treatments she has given her.Fda safety report id # (b)(4).

• Brand Name: THERMOGRAPHY
• Type of Device: SYSTEM, TELETHERMOGRAPHIC (ADJUNCTIVE USE)
• MDR Report Key: 12835705
• MDR Text Key: 281080319
• Report Number: MW5105450
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Race: White