MAUDE Adverse Event Report: ITOVI ITOVI SCANNER; DEVICE, GALVANIC SKIN RESPONSE MEASUREMENT

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Shock (2072)

Event Date 04/04/2018

Event Type  malfunction  

Event Description

Got a zap from the scanner."suspect: yes; primary: yes; did the problem stop after the person reduced the dose or stopped taking or using the product: yes.".

• Brand Name: ITOVI SCANNER
• Type of Device: DEVICE, GALVANIC SKIN RESPONSE MEASUREMENT
• Manufacturer (Section D): ITOVI
• MDR Report Key: 7665740
• MDR Text Key: 113513884
• Report Number: MW5078263
• Device Sequence Number: 1
• Product Code: GZO
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28 YR