ITOVI TRACKER 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 ITS10 - manufactured by Itovi.

Event Text Entries

[113464259] 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).
Patient Sequence No: 1, Text Type: N, H10


[113464260] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3014545134-2018-00102
MDR Report Key7670538
Report SourceCONSUMER
Date Received2018-07-09
Date of Report2018-04-10
Date of Event2018-04-09
Date Mfgr Received2018-04-09
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
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 S. 520 W SUITE 250
Manufacturer CityLINDON 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
Generic NameGALVANIC SKIN RESPONSE MEASUREMENT DEVICE, PRODUCT CODE: GZO
Product CodeGZO
Date Received2018-07-09
Returned To Mfg2018-04-30
Model NumberITS10
Catalog Number-
Lot Number032016
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerITOVI
Manufacturer Address355 S. 520 W SUITE 250 LINDON 84042 US 84042


Patients

Patient NumberTreatmentOutcomeDate
10 2018-07-09

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