MAUDE Adverse Event Report: BTL INDUSTRIES JSC EMSCULPT; STIMULATOR, MUSCLE, POWERED

Device Problem Product Quality Problem (1506)

Patient Problem Injury (2348)

Event Date 07/20/2020

Event Type  Injury  

Event Description

I used an emsculpt device per protocol and subsequently developed ovarian failure and menopause at the age of (b)(6) yr old due to the high intensity electromagnetic waves used by this machine.I had a fully functioning normal cycles and suddenly developed menopausal stamp yin's.I pursued much testing to evaluate if there was an organic cause for this ovarian failure but all testing was normal and my only exposure was to this device.I am thin and the device was directly on my ovaries.I have allow since found many studies that report ovarian injury and failure and rats after high intensity electromagnetic waves; pelvic ultrasound.Fda safety report id# (b)(4).

• Brand Name: EMSCULPT
• Type of Device: STIMULATOR, MUSCLE, POWERED
• Manufacturer (Section D): BTL INDUSTRIES JSC
• MDR Report Key: 10513807
• MDR Text Key: 206520517
• Report Number: MW5096497
• Device Sequence Number: 1
• Product Code: IPF
• 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: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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): Disability
• Patient Age: 43 YR
• Patient Weight: 54