MAUDE Adverse Event Report: SLENDERTONE

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Event Description

Diagnosed with the sudden onset of diverticulosis covering a large area of the colon during annual check up.This onset coincided with frequent (five to six days a week) use of ems apparatus (slendertone) over the previous 6 months in the abdominal area.There must be a strong probability that the severe contractions induced by this kind of apparatus might well cause the internal herniations that are diverticula.

• Brand Name: SLENDERTONE
• Type of Device: SLENDERTONE
• MDR Report Key: 5573397
• MDR Text Key: 42629033
• Report Number: MW5061649
• Device Sequence Number: 1
• Product Code: NGX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/09/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability