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	06/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient received a 2 x 2 cm deep partial thickness burn between two handpieces placed on the lower abdomen.The burn developed into a blister and was treated with polysporin, vaseline, and medi-honey.The patient's reported bmi is 33.8.The trusculpt id instructions for use state the following: caution: handpieces should be spaced based on the patient's bmi and/or underlying fat thickness in the treatment area to prevent adverse events.For bmi 26-30 or >1 cm fat thickness, place handpieces >1 cm apart.Up to 2 handpieces can be used on large or small decals, verifying 1 cm or more separation between handpieces." the burn resulted from insufficient separation between the handpieces placed on the lower abdomen.Specifically, three handpieces were positioned on a single decal, leading to insufficient space between the handpieces.The trusculpt id system was evaluated by cutera field service and met performance specifications.

• 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 ; 4156575575
• MDR Report Key: 19803092
• Report Number: 2954354-2024-00013
• Device Sequence Number: 20919767
• Product Code: GEI
• UDI-Device Identifier: 00816722021427
• UDI-Public: 010081672202142711230522
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K223110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/22/2024

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: Health Professional
• Device Model Number: TRUSCULPTID
• 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: 06/24/2024
• Initial Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2023
• 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 Age: 40 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White