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

Model Number	TRUSCULPTID
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	09/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intense sweating can contribute to the formation of burns due to pooling of sweat causing localized areas of concentrated energy.The root cause was determined to be failure to follow instructions for use, which advise user to: check the treatment area during treatment for excessive sweat/moisture and pause and dab-dry the area if needed.Pause treatment if the patient is experiencing pain and observe the patient's skin for any signs of epidermal damage.Stop treatment if any epidermal damage is observed; and if no epidermal damage is observed, ensure that the skin is dry before resuming treatment.In addition, cutera does not have a record of the device operator attending a trusculpt id clinical training.
Event or Problem Description
The patient (adult male) experienced a deep dermal burn in a crescent shape at the corner of the rf electrode, which was placed on the patient's left flank area (lower back).The device operator reported that the patient's pain and perspiration levels were 9 out of 10 during the procedure.Wound care involves applying antibiotic ointment and covering the area until fully healed.

• 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 (Section G): CUTERA, INC.; 3240 bayshore blvd; brisbane CA 94005
• Manufacturer Contact: julia brown ; 3240 bayshore blvd; brisbane, CA 94005 ; 4156575575
• MDR Report Key: 20379177
• Report Number: 2954354-2024-00017
• Device Sequence Number: 13168736
• Product Code: GEI
• UDI-Device Identifier: 00816722021427
• UDI-Public: 010081672202142711221130
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K223110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/05/2024

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: Other
• Device Model Number: TRUSCULPTID
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 10/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2022
• 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: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White