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

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Hematoma (1884); Partial thickness (Second Degree) Burn (2694)

Event Date 12/29/2021

Event Type  Injury  

Event 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
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BTL INDUSTRIES INC.
• MDR Report Key: 15210550
• MDR Text Key: 297895774
• Report Number: MW5111429
• Device Sequence Number: 1
• Product Code: GEI
• 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: 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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2022
• Patient Sequence Number: 1
• Treatment: JOLESSA BIRTH CONTROL PILL; MULTIVITAMIN
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White