MAUDE Adverse Event Report: UNKNOWN BIOFEEDBACK ALLERGY DEVICE; DEVICE, BIOFEEDBACK

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

I previously went to this provider for biofeedback allergy treatments.They did not work for me and i stopped patronizing the establishment.I did my own research and found their claims to not be based on scientific data.Recently, my primary care physician referred me to them again.Upon conducting further research, it seems they are operating outside of the law by claiming to diagnose and treat allergies based on biofeedback devices.Here is the link to their website: https://becomeallergyfree.Com/about-us-allergy-treatment-options/.

• Brand Name: BIOFEEDBACK ALLERGY DEVICE
• Type of Device: DEVICE, BIOFEEDBACK
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 18103994
• MDR Text Key: 328005394
• Report Number: MW5148007
• Device Sequence Number: 1
• Product Code: HCC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White