ITOVI SCANNER ITS15

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 2018-06-15 for ITOVI SCANNER ITS15 manufactured by Itovi.

MAUDE Entry Details

Report Number0000000-2018-00103
MDR Report Key7605503
Report SourceCONSUMER
Date Received2018-06-15
Date of Report2018-01-10
Date of Event2018-01-10
Date Mfgr Received2018-01-11
Device Manufacturer Date2017-09-01
Date Added to Maude2018-06-15
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
Event Type3
Type of Report3

Device Details

Brand NameITOVI SCANNER
Generic NameGALVANIC SKIN RESPONSE MEASUREMENT DEVICE, PRODUCT CODE: GZO
Product CodeGZO
Date Received2018-06-15
Returned To Mfg2018-05-07
Model NumberITS15
Lot Number092017
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerITOVI
Manufacturer Address355 SOUTH 520 WEST SUITE 250 LINDON 84042 US 84042


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-06-15

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