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

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

Patient Problems Menstrual Irregularities (1959); Hot Flashes/Flushes (2153)

Event Date 10/26/2021

Event Type  Injury  

Event Description

I had regular cycles until i received emsculpt treatments on my abdomen.I have a 26 day cycle.I had 1 30 minute trial session and then 4, 1 hour sessions in the month of (b)(6) 2021 (1 session per week).My last normal cycle was (b)(6) 2021; i was expecting a period on (b)(6) 2021, but it never came.The same for (b)(6), which should have arrived (b)(6) 2021.I have not had a cycle since (b)(6) 2021 and have been experiencing hot flashes.Thus far, i have missed 2 periods (b)(6).I recognize that i am of menopause age and perhaps it is a coincidence, but i had no symptoms or indications my cycles would end prior to the emsculpt treatments.I believe it is a case of ovarian failure as a consequence of these treatments given the sudden onset and no other symptoms prior.Fda safety report id# (b)(4).

• Brand Name: EMSCULPT
• Type of Device: STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING
• Manufacturer (Section D): BTL INDUSTRIES, JSC.
• MDR Report Key: 12925074
• MDR Text Key: 281763993
• Report Number: MW5105761
• Device Sequence Number: 4
• Product Code: NGX
• 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: 12/01/2021
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/02/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Other
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White