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

Model Number ITS10

Device Problem Installation-Related Problem (2965)

Patient Problem Hematoma (1884)

Event Date 04/09/2018

Event Type  Injury  

Manufacturer Narrative

Specification developer and finished product manufacturer: establishment: itovi (b)(4).Status: active; awaiting assignment of registration number.Date of registration status: 2018.Owner/operator: itovi (b)(4).Proprietary name: itovi.Classification name: device, galvanic skin response measurement.Product code: gzo.Device class: 2.Regulation number: (b)(4).Medical specialty: neurology.Registered establishment name: itovi.Owner/operator: itovi.Owner/operator number: (b)(4).Establishment operations: manufacturer.Complaint file establishment for ivovi: (b)(4).Status: active.Initial distributor/importer: no.Note firm may have additional establishment types.Please review listings for further information.Date of registration status: 2018.Owner/operator: (b)(4).Owner/operator number: (b)(4).Official correspondent: (b)(4).

Event Description

Via an e-mail to the finished product manufacturer/ specification developer on (b)(6) 2018, the complainant reported that on/around (b)(6) 2018, he received a blood blister when using the itovi device (i.E.While scanning and unplugged from a power source).The finished product manufacturer/ specification developer requested the unit to be returned back for evaluation.

• Brand Name: ITOVI TRACKER
• Type of Device: GALVANIC SKIN RESPONSE MEASUREMENT DEVICE, PRODUCT CODE: GZO
• Manufacturer (Section D): ITOVI; 355 s. 520 w; suite 250; lindon 84042
• Manufacturer (Section G): ITOVI; 355 s. 520 w; suite 250; lindon 84042
• Manufacturer Contact: michael wadman ; 355 s. 520 w; suite 250; lindon 84042 ; 8016150636
• MDR Report Key: 7670538
• MDR Text Key: 113464259
• Report Number: 3014545134-2018-00102
• Device Sequence Number: 1
• Product Code: GZO
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ITS10
• Device Catalogue Number: -
• Device Lot Number: 032016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Date Manufacturer Received: 04/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 0000000-06/08/18-001-R
• Patient Sequence Number: 1
• Patient Age: 35 YR