ITOVI TRACKER/SCANNER ITS10 -

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-07-09 for ITOVI TRACKER/SCANNER ITS10 - manufactured by Itovi.

Event Text Entries

[113457965] 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.
Patient Sequence No: 1, Text Type: N, H10


[113457966] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3014545134-2018-00101
MDR Report Key7670547
Report SourceCONSUMER
Date Received2018-07-09
Date of Report2017-09-20
Date of Event2017-09-20
Date Mfgr Received2017-09-20
Device Manufacturer Date2016-03-01
Date Added to Maude2018-07-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. MICHAEL WADMAN
Manufacturer Street355 S. 520 W SUITE 250
Manufacturer CityLINDON 84042
Manufacturer CountryUS
Manufacturer Postal84042
Manufacturer Phone8016150636
Manufacturer G1ITOVI
Manufacturer Street355 SOUTH 520 WEST SUITE 250
Manufacturer CityLINDON UT 84042
Manufacturer CountryUS
Manufacturer Postal Code84042
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction Number0000000-06/08/18-001-R
Event Type3
Type of Report3

Device Details

Brand NameITOVI TRACKER/SCANNER
Generic NameGALVANIC SKIN RESPONSE MEASUREMENT DEVICE
Product CodeGZO
Date Received2018-07-09
Model NumberITS10
Catalog Number-
Lot Number032016
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerITOVI
Manufacturer Address355 SOUTH 520 WEST SUITE 250 LINDON UT 84042 US 84042


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-07-09

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