MAUDE Adverse Event Report: INCONTROL MEDICAL INTONE; STIMULATOR, ELECTRICAL

Model Number INTONE

Device Problems Deflation Problem (1149); Inappropriate/Inadequate Shock/Stimulation (1574); Defective Device (2588)

Patient Problems Cramp(s) (2193); Discomfort (2330); Electric Shock (2554)

Event Date 10/16/2014

Event Type  Injury  

Event Description

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.

• Brand Name: INTONE
• Type of Device: STIMULATOR, ELECTRICAL
• Manufacturer (Section D): INCONTROL MEDICAL
• MDR Report Key: 4466470
• MDR Text Key: 5397641
• Report Number: MW5040478
• Device Sequence Number: 1
• Product Code: KPI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: INTONE
• Device Lot Number: NB13202A1
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Weight: 116