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

Device Problem Failure to Charge (1085)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  No Answer Provided  

Event Description

I did not have any issues with the product other than it would not hold a charge.

• Brand Name: ITOVI
• Type of Device: DEVICE, GALVANIC SKIN RESPONSE MEASUREMENT
• Manufacturer (Section D): ITOVI
• MDR Report Key: 7663484
• MDR Text Key: 113308234
• Report Number: MW5078243
• 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: 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 Weight: 91