MAUDE Adverse Event Report: CUTERA, INC. TRUSCULPT ID

Model Number	TIDF10957
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	10/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Full thickness burns on the lower abdomen following trusculpt id treatment.
Additional Manufacturer Narrative
Cutera's key account manager reported that on thursday, november 16, 2023, she was present at the customer site when the following incident took place, relating to the trusculpt id device.Their first model was treated with the trusculpt id and used all 6 panels straight across.The said patient did the full 15 min treatment.She got her skin temperature up to 44 degrees.Towards the end of the treatment, the patient mentioned that she was getting hot; the temperature was thus reduced by 1/2 degree where she was able to tolerate it.When handpieces were removed, everything looked fine, no blisters.Just some redness as expected.Couple of days later, device user reported that the patient reported burns and was treating them.The device user followed up with the patient, and patient reported that she was healing and was ok.The patient said she was using a topical cream.On december 2, 2023, cutera's key account manager received patient pictures, with two visible linear third degree burns on the patient's lower abdomen.Cutera opened an investigation and deemed this incident to be reportable.Cutera is in the process of following up with the clinic to obtain more information about this incident.
Additional Manufacturer Narrative
The full investigation report is attached, and its primary findings are summarized below: based on the skin-temperature data captured during the treatment and the initial report of the event made by kam carrie soell who was present during the treatment, we believe that the root cause of the two linear burns was that the user placed hp1, hp2, and hp3 on a single large decal on the patient's lower left abdomen, with insufficient separation between hp2 and hp3 for the patient's bmi of 44, and hp4, hp5, and hp6 on a single large decal on the patient's lower right abdomen, with insufficient separation between hp4 and hp5 for the patient's bmi of 44, again both contrary to the ifu.
Event or Problem Description
Full thickness burns on the lower abdomen following trusculpt id treatment.

• Brand Name: TRUSCULPT ID
• Common Device Name: TRUSCULPT ID
• 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: 18387583
• Report Number: 2954354-2023-00002
• Device Sequence Number: 2699542
• Product Code: PBX
• UDI-Device Identifier: 00816722021427
• UDI-Public: 00816722021427
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K180709
• 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: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2024

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
• Device Model Number: TIDF10957
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 55 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White