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

Device Problem Nonstandard Device (1420)

Patient Problem No Information (3190)

Event Type  No Answer Provided  

Event Description

Product was recalled.

• Brand Name: ITOVI TRACKER
• Type of Device: DEVICE, GALVANIC SKIN RESPONSE MEASUREMENT
• Manufacturer (Section D): ITOVI
• MDR Report Key: 7663530
• MDR Text Key: 113332106
• Report Number: MW5078250
• 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: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 67