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	Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)
Date of Event	01/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A 1 inch x 0.5 inch blister developed 4 hours after trusculpt id treatment to the "triceps".The blister was located at the lower edge of the return pad electrode, which was placed on the upper back.The wound is consistent with a deep partial thickness/full thickness burn that was treated with non-prescription antibiotic ointment (fucidin), 3m second skin moist burn pads, and 3m hydrocolloid dressing.The root cause was determined to be insufficient separation between the return pad (on patient's upper right back) and the nearest handpiece (on patient's right rear arm) for the thickness of subcutaneous fat under the handpiece.There is not a device performance complaint associated with the event.The trusculpt id system was evaluated by the field service engineer, and the device was determined to meet 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 (Section G): CUTERA, INC.; 3240 bayshore blvd; brisbane CA 94005
• Manufacturer Contact: julia brown ; 3240 bayshore blvd; brisbane, CA 94005 ; 4156575575
• MDR Report Key: 18759775
• Report Number: 2954354-2024-00002
• Device Sequence Number: 12412668
• Product Code: GEI
• UDI-Device Identifier: 00816722021427
• UDI-Public: 00816722021427
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K221407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/22/2024

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: Other
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 02/22/2024
• 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: 40 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White