MAUDE Adverse Event Report: TENSCARE LTD TENSCARE ITOUCH SURE; STIMULATOR, ELECTRICAL, NON-IMPLANTABLE, FOR INCONTINENCE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Vomiting (2144); Cancer (3262)

Event Date 02/20/2019

Event Type  Injury  

Event Description

I started using a tenscare itouch sure pelvic floor stimulator and toner almost every day in (b)(6) 2019.Within a week i noticed a small lump on my lower abdomen but assumed it was food or gas and didn't pay it anymore attention.Within a month the lump had grown substantially and i was experiencing health problems such as pain and vomiting.Within two months the lump was discovered to be a 7lb tumor and had forced my intestines into my stomach causing me to vomit feces and undergo emergency surgery resulting in total loss of fertility.I have no personal nor family history of any type of tumor.This tumor grew immediately after starting my tens machine regimen and progressed abnormally rapidly.I have medical documentation of my lack of tumor in (b)(6) and the 7lb tumor in (b)(6).Fda safety report id # (b)(4).

• Brand Name: TENSCARE ITOUCH SURE
• Type of Device: STIMULATOR, ELECTRICAL, NON-IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): TENSCARE LTD
• MDR Report Key: 8722538
• MDR Text Key: 148994924
• Report Number: MW5087505
• Device Sequence Number: 1
• Product Code: KPI
• Combination Product (y/n): N
• 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: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Disability
• Patient Age: 36 YR
• Patient Weight: 57