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

Model Number	TRUSCULPT ID
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	06/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The 16 cm2 handpiece was used to treat the submentum and neck area.The trusculpt id operator manual instructs the device operator not to treat "on the head or on the neck (including carotid sinus or over the trachea or thyroid cartilage)".The patient experienced a small, linear, deep partial thickness burn on the side of the neck.The wound management is bacitracin.The device is pending inspection and testing by cutera service.
Event or Problem Description
This is a follow-up to the initial emdr filed on july 5, 2024.As reported initially, the 16 cm2 handpiece was used to treat the submentum and neck area.The trusculpt id operator manual instructs the device operator not to treat "on the head or on the neck (including carotid sinus or over the trachea or thyroid cartilage)".The patient experienced a small, linear, deep partial thickness burn on the side of the neck.The wound management was bacitracin.The area healed with a visible linear scar.At the time of the initial emdr, cutera was awaiting return of the handpiece for inspection and testing.However, the customer has chosen not to return the handpiece and has declined a field service visit.

• 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: 19684674
• Report Number: 2954354-2024-00011
• Device Sequence Number: 14255893
• Product Code: GEI
• UDI-Device Identifier: 00816722021427
• UDI-Public: 010081672202142711190403
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: 223110
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2024

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: TRUSCULPT ID
• 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: 06/12/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 07/05/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2019
• 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: 43 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White