INTONE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-01-21 for INTONE manufactured by Incontrol Medical.

Event Text Entries

[5397641] Purchased an incontrol medical intone device through my ob-gyn on (b)(6) 2014. When i used the intone device at home, it shocked me and made me feel very uncomfortable afterwards. At my follow-up appointment with the ob-gyn on (b)(6) 2014, i asked for a refund and was told that they would contact incontrol to find out how to process the refund, a few days later she put me in direct contact with the company and directed me to speak with (b)(6). After speaking with (b)(6), the unit was deemed defective (deflating issue). Intone medical replaced the unit and (b)(6) encouraged me to try using the device again and if i was still having issues, then she would see about 'doing something'. After trying the replacement device, i was still feeling very uncomfortable and crampy for a full day afterwards. When i called (b)(6) and incontrol to let her know that the device was still causing me issues, she curtly informed me that since i had used the replacement device, there would be no refund. When i pointed out that the only reason that i used the replacement device was at her urging and reassurance that i would not be uncomfortable, she restated the company's no refund policy and said that if i hadn't used the replacement device, they would have taken it back. I feel that this was very misleading. The fact that the first device was shocking internally and something like that got sold to a consumer followed with my experience of a 'working' device that leaves me feeling unwell for a full 24 hours after using it is troublesome.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5040478
MDR Report Key4466470
Date Received2015-01-21
Date of Report2015-01-21
Date of Event2014-10-16
Date Added to Maude2015-01-30
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameINTONE
Generic NameSTIMULATOR, ELECTRICAL
Product CodeKPI
Date Received2015-01-21
Model NumberINTONE
Lot NumberNB13202A1
OperatorLAY USER/PATIENT
Device Sequence No1
Device Event Key0
ManufacturerINCONTROL MEDICAL


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2015-01-21

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