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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	06/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, a 61 year old female underwent trusculpt id treatment to the abdomen using six handpieces.The patient reportedly did not experience pain or excessive heat during treatment.A burn to the lower abdomen was subsequently reported.The available documentation contains an inconsistency regarding when the patient first reported the event to the clinic.One record states that the patient notified the clinic on (b)(6) 2026; however, the clinic had reported the event to cutera on (b)(6) 2026.Therefore, the date the patient first notified the clinic cannot be confirmed.A photograph of the wound that was provided for review is labeled (b)(6) 2026; however, the date the photograph was taken, the accuracy of the displayed date, and the identity of the person who took the photograph have not been confirmed.The wound in the photo appears aged and to involve full-thickness tissue injury.The patient reportedly underwent wound debridement and treatment with hydrocolloid dressings.As of (b)(6) 2026, the area was reported to be still healing.No device malfunction or abnormal operation was reported in association with the treatment.Preventive maintenance was performed on (b)(6) 2026, 49 days, or 7 weeks, before the (b)(6) 2026 treatment.At that time, the system was documented as operating within factory specifications.Based on the available information, the cause of the reported burn cannot be determined.Wounds and burns are identified in the instructions for use as possible adverse effects.

• 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: 50382143
• Report Number: 2954354-2026-00006
• Device Sequence Number: 15893707
• 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: Health Professional,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: 61 YR
• Patient Sex: Female
• Patient Race: Black Or African American