MAUDE Adverse Event Report: MEDITHERM INC. MEDTHERM IRIS; SYSTEM, TELETHERMOGRAPHIC (ADJUNCTIVE USE)

Device Problem Calibration Problem (2890)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/15/2020

Event Type  malfunction  

Event Description

Longevity thermography is a company practicing thermography and offering ultrasound in many eastern states, without any kind of business license.The website is very misleading and is causing women to avoid mammograms.Their cameras are not recently calibrated and as such cannot be relied on to accurately perform the scans they say they can.With out dated and uncalibrated equipment this company is a risk to thousands of lives.Please do something.Fda safety report id# (b)(4).

• Brand Name: MEDTHERM IRIS
• Type of Device: SYSTEM, TELETHERMOGRAPHIC (ADJUNCTIVE USE)
• Manufacturer (Section D): MEDITHERM INC.
• MDR Report Key: 9621778
• MDR Text Key: 176387428
• Report Number: MW5092408
• 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: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR