MAUDE Adverse Event Report: THERMOGRAM

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Operates Differently Than Expected (2913)

Patient Problem Breast Cancer (1759)

Event Date 05/11/2017

Event Type  Injury  

Event Description

Was receiving screening thermograms as a screening for breast cancer under the care of (b)(6) in (b)(6).She was told that this could be used to deflect breast cancer and was told that her thermograms were "negative for cancer".She felt a mass in her breast.There is a 3 cm mass in her breast that is cancer.

• Brand Name: THERMOGRAM
• Type of Device: THERMOGRAM
• MDR Report Key: 6566405
• MDR Text Key: 75256534
• Report Number: MW5069732
• Device Sequence Number: 1
• Product Code: ONO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 60 YR
• Patient Weight: 68