MAUDE Adverse Event Report: CUTERA, INC. TRUSCULPT ID; MASSAGER, VACUUM, RADIO FREQUENCY INDUCED HEAT

Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Localized Skin Lesion (4542); Subcutaneous Nodule (4548)
Date of Event	04/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
An adult female patient received a trusculpt treatment to the neck area.After the procedure, the treating physician observed a linear, raised, and firm lesion with an underlying nodule on the anterior upper neck.The skin remained intact, and the lesion was described as a horizontal line.The physician noted that the lesion did not appear to be a burn.The patient declined a full clinical evaluation and did not provide details about when the skin changes began.However, she requested antibiotic treatment, and the physician prescribed bactrim ds (taken orally twice daily for 7 days).The patient also visited an urgent care clinic, where she was prescribed triamcinolone cream.The physician did not report any concerns related to the performance of the trusculpt system, and no device malfunction was identified.A photo of the lesion was provided, but no specific information about the treatment settings or the outcome of the lesion has been received.Attempts by cutera to obtain additional follow-up details have not been successful.The trusculpt instructions for use state that the device should not be used to treat the neck.The decision to treat this area was made by the practitioner.Cutera is submitting this report in good faith to meet regulatory reporting requirements, based on the clinical appearance of a persistent linear lesion and the potential for scar formation or an undesirable cosmetic outcome.There is no indication of device malfunction or failure.

• 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
• MDR Report Key: 22064635
• Report Number: 2954354-2025-00002
• Device Sequence Number: 18095699
• Product Code: GEI
• UDI-Device Identifier: 00816722021427
• UDI-Public: 010081672202142711230923
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K221407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/21/2025

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2025
• Initial Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2023
• 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 Sex: Female
• Patient Race: White