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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Nodule (4551)

Event Date 06/09/2023

Event Type  Injury  

Event Description

Emsculpt neo on quads now have a hard lump on each quad where applicator was placed.

• Brand Name: EMSCULPT NEO
• Type of Device: STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING
• Manufacturer (Section D): BTL INDUSTRIES JSC
• MDR Report Key: 17218742
• MDR Text Key: 318138179
• Report Number: MW5118893
• Device Sequence Number: 1
• 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: Other
• Type of Report: Initial
• Report Date: 06/24/2023

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?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/27/2023
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White