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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)

Event Date 01/18/2024

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 336011435
• Report Number: 2954354-2024-00002
• Device Sequence Number: 1
• Product Code: GEI
• 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,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 40 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White