MAUDE Adverse Event Report: BRAINSWAY LTD. BRAINSWAY; TRANSCRANIAL MAGNETIC STIMULATION SYSTEM FOR OBSESSIVE-COMPULSIVE DISORDER

Device Problem Malposition of Device (2616)

Patient Problem Headache (1880)

Event Date 05/11/2022

Event Type  Injury  

Event Description

I was getting brainsway tms.Helmet was not placed right and giving me headaches every day on right side.Fda safety report id # (b)(6).

• Brand Name: BRAINSWAY
• Type of Device: TRANSCRANIAL MAGNETIC STIMULATION SYSTEM FOR OBSESSIVE-COMPULSIVE DISORDER
• Manufacturer (Section D): BRAINSWAY LTD.
• MDR Report Key: 14470472
• MDR Text Key: 292497280
• Report Number: MW5109814
• Device Sequence Number: 1
• Product Code: QCI
• 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: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Patient Sequence Number: 1
• Treatment: MAGNESIUM; MULTIVITAMIN
• Patient Age: 37 YR
• Patient Ethnicity: Non Hispanic