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

Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6), 2024, a patient contacted cutera to report they suffered burns on their lower right abdomen during a trusculpt id treatment performed at inovo medical located in gloucester, ontario, canada.The patient included an undated photo with the initial report that shows what appears to be a healing deep partial thickness burn (~2 cm x ~1 cm) and a superficial partial thickness burn (~1 cm x ~0.3 cm) on a stretch mark on the patient's right lower abdomen.Cutera opened a complaint investigation and has reached out to the site the patient reported as performing the treatment.The site stated they are unwilling to provide any information about the treatment or cooperate in the investigation unless the patient reports the burns to them and returns to be examined.

• 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: 18965533
• Report Number: 2954354-2024-00004
• Device Sequence Number: 8161152
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/22/2024

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2024
• Initial Report FDA Received Date: 03/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2019
• 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 Sex: Male