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

Model Number ITS10

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Date 09/20/2017

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).Official correspondent: (b)(4).Proprietary name: itovi classification name: device, galvanic skin response measurement.Product code: gzo.Device class: 2.(b)(4).Medical specialty: neurology.Registered establishment name: itovi.Owner/operator: itovi.Owner/operator number: (b)(4).Establishment operations: manufacturer.Complaint file establishment for specification developer and finished product manufacturer.Establishment: hudson scientific llc (b)(4).Status: active.*note firm may have additional establishment types.Please review listings for further information.Date of registration status: 2018.Owner/operator: hudson scientific llc (b)(4).Official correspondent: (b)(4), registered establishment name: hudson scientific llc.(b)(4).Owner/operator: hudson scientific llc.(b)(4).Establishment operations: complaint file establishment.Specification developer and finished product manufacturer is in the process of redesigning a new medical device for subsequent replacement.

Event Description

From (b)(6) 2016- (b)(6) 2017 and (b)(6) 2018, there were various discussions between the complainant and the formally designated complaint units.During initial discussions on (b)(6) 2017- (b)(6) 2017, the complainant complained to the finished product manufacturer/ specification developer that on/around (b)(6) 2017, (a) she (adult female) had chest pains while using the itovi device (i.E while scanning, but having the unit unplugged from the power source); and (b) an adult male and a male child (i.E.(b)(6) toddler) were hurt while using the device (i.E scanning but having the unit be unplugged from the power source).From additional discussions on 4/30/2018, the complainant explained the problem in more detail and alleged to the complaint filing establishment that (a) she (adult female) received an electric shock while using the itovi device (i.E.While scanning but having the unit unplugged from the power source) that later caused her to have knots on her arm between the elbow and wrist, lose strength in both hands and arms, and tingling sensations and electric current in her fingertips, shoulder, arm, and both hands which lasted a few days during and after usage (in which she sought medical attention from her chiropractor 4-5 times, the chiropractor said she may have suffered an accidental shock); (b) the itovi device also caused the complainant to loose work as a massage therapist because she became weak, had pains, and fatigue.Additionally, the symptoms caused to her have to pulling off the road while driving (i.E.Due to her having instant knots underneath her skin, pain in her fingertips.Chest pain, and a migraine headache); and (c) after initial usage by the complainant, the same and/or another itovi device was then used on a mother (i.E.An adult female who was previously diagnosed with epilepsy), a husband (i.E.An adult male), and their two children (i.E.A male (b)(6) and a male newborn) (i.E.Either friends or relatives of the complainant) on/around (b)(6) 2017, who also alleged that the itovi device caused (i) the mother to maybe have epileptic type symptoms, but actually have a headache, be lightheaded, be lethargic, and be frustrated and hostile (i.E.Very untypical behaviors from the mother) while using and after usage for a day; (ii) the husband to have a migraine headache, not feeling well, and having sensations in both hands (i.E.Like his hands were in an electrically charged bucket) while using and after usage for over a day; (iii) the newborn to have a loss of appetite, crying in the evening, would not snuggle with the parents, and was beside himself during and for at several hours after using the device; and (iv) the (b)(6) toddler to have a meltdown after usage until bedtime.Also, besides the complainant and her relatives/ friends (i.E.The adult mother, adult husband and their 2 children), the complainant also had two additional male children (ages 8 and 9 or 10) use the itovi device in which one boy complained of being hurt from touching the device's silver balls and having weird feelings, acting strange, and needing to lay down during and/or after usage.It is unknown as to whether the other child had an adverse effect from using the device.Lastly, the complainant also alleged that the itovi device caused her to jerk her neck, become dizzy, have a migraine, loose strength in her hand and fingers, and not be able to work (thus causing her to change her plans).It is unknown whether the other users sought medical attention because the complainant refused to speak to the formally designated complaint unit after the (b)(6) 2018 telecom.

• Brand Name: ITOVI TRACKER/SCANNER
• Type of Device: GALVANIC SKIN RESPONSE MEASUREMENT DEVICE
• Manufacturer (Section D): ITOVI; 355 south 520 west; suite 250; lindon UT 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: 7670547
• MDR Text Key: 113457965
• Report Number: 3014545134-2018-00101
• 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: 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/20/2017
• Initial Date FDA Received: 07/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: Unknown
• Removal/Correction Number: 0000000-06/08/18-001-R
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 35 YR