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

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Breast Cancer (1759)

Event Date 01/08/2019

Event Type  Injury  

Event Description

New palpable breast lump, got thermogram (b)(6) 2019 at (b)(6)/ interpreted as low risk with recommendation for 3 month f/u.The pt is now hospitalized with widely metastatic breast cancer.In a (b)(6) y/o woman with a palpable mass in her breast and a positive family history, a mammogram and ultrasound are indicated.This exam result falsely reassured the pt and delayed diagnosis and treatment.Now, there is no cure for her disease.Fda safety report id# (b)(4).

• Brand Name: THERMOGRAPHY
• Type of Device: SYSTEM, TELETHERMOGRAPHIC (ADJUNCTIVE USE)
• MDR Report Key: 8487644
• MDR Text Key: 141252247
• Report Number: MW5085624
• 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: Physician
• Type of Report: Initial
• Report Date: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR
• Patient Weight: 38