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

Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Nodule (4551)
Date of Event	06/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Emsculpt neo on quads now have a hard lump on each quad where applicator was placed.

• Brand Name: EMSCULPT NEO
• Common Device Name: STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING
• Manufacturer (Section D): BTL INDUSTRIES JSC
• MDR Report Key: 17218742
• Report Number: MW5118893
• Device Sequence Number: 11132169
• Product Code: NGX
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Other
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 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