ITOVI TRACKER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-03 for ITOVI TRACKER manufactured by Itovi.

Event Text Entries

[113332106] Product was recalled.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5078250
MDR Report Key7663530
Date Received2018-07-03
Date of Report2018-07-02
Date Added to Maude2018-07-05
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameITOVI TRACKER
Generic NameDEVICE, GALVANIC SKIN RESPONSE MEASUREMENT
Product CodeGZO
Date Received2018-07-03
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerITOVI


Patients

Patient NumberTreatmentOutcomeDate
10 2018-07-03

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