MAUDE Adverse Event Report: Cutera, Inc. truSculpt iD; Massager, Vacuum, Radio Frequency Induced Heat

Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Wound Infection (2447); Full thickness (Third Degree) Burn (2696)
Date of Event	07/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, a 43-year-old female underwent trusculpt id treatment to the bilateral bra-fat and mid-back areas.Return pads were reported to have been placed on the upper back.Following treatment, a blister was noted at the lower edge of a return pad electrode on one side of the back; a second blister was reported the following day on the opposite side.The affected areas were described as bilateral mid-back burns near the inferior edge of the scapulae.A hydrocolloid dressing was applied, an antibiotic was prescribed, and bandages were provided.As (b)(6) 2026, the areas were reported to be still healing.No device malfunction, abnormal operation, or error messages were reported.The actual distance between the treatment handpieces and return pads could not be confirmed.The instructions for use specify a minimum 4-inch (10 cm) separation when treating near the return pads.Insufficient separation cannot be ruled out; however, the cause of the event cannot be definitively determined from the available information.The mid-back treatment is outside of the identified indication for the 2 mhz setting with the 40 cm2 handpiece.

• Brand Name: truSculpt iD
• Common Device Name: Massager, Vacuum, Radio Frequency Induced Heat
• Manufacturer (Section D): Cutera, Inc.; 3240 bayshore blvd.; brisbane CA 94005
• Manufacturer Contact: julia brown ; 3240 bayshore blvd.; brisbane, CA 94005 ; +1(415)657-5500
• MDR Report Key: 50382136
• Report Number: 2954354-2026-00004
• Device Sequence Number: 13215957
• Product Code: GEI
• UDI-Device Identifier: 00816722021427
• UDI-Public: 01008167220214271118102421TIDF10129
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K221407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/21/2026

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?: No
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Race: White