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

Model Number ITOVI TRACKER

Device Problem Nonstandard Device (1420)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  No Answer Provided  

Event Description

Instructed by seller to complete this form, due to a massive recall, so they can exchange my device.I personally did not experience any problems with my itovi device.

• Brand Name: ITOVI SCANNER
• Type of Device: DEVICE, GALVANIC SKIN RESPONSE MEASUREMENT
• Manufacturer (Section D): ITOVI
• MDR Report Key: 7670788
• MDR Text Key: 113513879
• Report Number: MW5078284
• Device Sequence Number: 1
• Product Code: GZO
• 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: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ITOVI TRACKER
• Device Catalogue Number: FCC ID: 2AGL3-TOV20021
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Weight: 64