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

Model Number ITS15

Device Problem Protective Measures Problem (3015)

Patient Problems Palpitations (2467); Electric Shock (2554)

Event Date 01/10/2018

Event Type  Injury  

• Brand Name: ITOVI SCANNER
• Type of Device: GALVANIC SKIN RESPONSE MEASUREMENT DEVICE, PRODUCT CODE: GZO
• Manufacturer (Section D): ITOVI; 355 south 520 west; suite 250; lindon 84042
• Manufacturer (Section G): ITOVI; 355 south 520 west; suite 250; lindon UT 84042
• Manufacturer Contact: michael wadman ; 355 s. 520 w; suite 250; lindon 84042 ; 8016150636
• MDR Report Key: 7605503
• Report Number: 0000000-2018-00103
• Device Sequence Number: 1
• Product Code: GZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ITS15
• Device Lot Number: 092017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR