• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BTL INDUSTRIES JSC EMSCULPT STIMULATOR, MUSCLE, POWERED Back to Search Results
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).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEMSCULPT
Type of DeviceSTIMULATOR, MUSCLE, POWERED
Manufacturer (Section D)
BTL INDUSTRIES JSC
MDR Report Key10513807
MDR Text Key206520517
Report NumberMW5096497
Device Sequence Number1
Product Code IPF
Reporter Country CodeUS
Number of Events Reported1
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 Received09/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 09/09/2020 Patient Sequence Number: 1
-
-