MAUDE Adverse Event Report: BIOFEEDBACK TRAINING; DEVICE, BIOFEEDBACK

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Headache (1880); Muscular Rigidity (1968); Sleep Dysfunction (2517)

Event Type  Injury  

Event Description

Got sick, sleep problem.Cbt for insomnia, irt for nightmare.A referral was put in from dr for treating, start receiving treatment and getting side effects, stomach pain, sleeping problems, got very very sick, headache."electrical serous," physical functions, muscles tension.

• Brand Name: BIOFEEDBACK TRAINING
• Type of Device: DEVICE, BIOFEEDBACK
• MDR Report Key: 13976442
• MDR Text Key: 288494286
• Report Number: MW5108677
• Device Sequence Number: 1
• Product Code: HCC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 118 KG
• Patient Race: Black Or African American