MAUDE Adverse Event Report: BTL INDUSTRIES INC. EMSCULPT NEO; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Health Effect - Clinical Codes	Hematoma (1884); Partial thickness (Second Degree) Burn (2694)
Date of Event	12/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Emsculpt neo treatment device caused burn to skin (mid suprapubic with a 2 cm open erosion of the skin).The bottom portion of the device was resting on the area that was burned.The treatment also caused suspected abdominal hematoma - extreme tenderness to palpitation of lower right abdominal area muscle that took approximately 10 weeks to resolve.Fda safety report id# (b)(4).

• Brand Name: EMSCULPT NEO
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BTL INDUSTRIES INC.
• MDR Report Key: 15210550
• Report Number: MW5111429
• Device Sequence Number: 6346812
• Product Code: GEI
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 08/09/2022

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: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/10/2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: JOLESSA BIRTH CONTROL PILL; MULTIVITAMIN
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White