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

Device Problem Insufficient Information (3190)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 338432510
• Report Number: 2954354-2024-00004
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00816722021427
• UDI-Public: 00816722021427
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K221407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/16/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male