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

Model Number	TRUSCULPT ID
Medical Device Problem Codes	Circuit Failure (1089); Electrical Shorting (2926)
Health Effect - Clinical Codes	Injury (2348); Patient Problem/Medical Problem (2688); Partial thickness (Second Degree) Burn (2694)
Date of Event	03/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device operator report "error codes" during the procedure.The handpiece has returned to the manufacturer for compressive testing.A follow up report will submitted after the analysis is complete.
Event or Problem Description
2 linear blisters on the treatment area (abdomen).The handpiece associated with the treatment has been returned to cutera for comprehensive testing.
Event or Problem Description
2 linear blisters on the treatment area (abdomen).The handpiece associated with the treatment was returned to cutera for comprehensive testing.

• Brand Name: TRUSCULPT ID
• Common Device Name: MASSAGER, VACUUM, RADIO FREQUENCY INDUCED HEAT
• Manufacturer (Section D): CUTERA, INC; 3240 bayshore blvd; brisbane CA 94005
• MDR Report Key: 8538173
• Report Number: 2954354-2019-00001
• Device Sequence Number: 16221694
• Product Code: PBX
• UDI-Device Identifier: 00816722022462
• UDI-Public: 010081672202246211181026
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K180709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2019

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
• Device Model Number: TRUSCULPT ID
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2019
• Initial Date Received by Manufacturer: 03/26/2019
• Supplement Date Received by Manufacturer: 03/26/2019
• Initial Report FDA Received Date: 04/22/2019
• Supplement Report FDA Received Date: 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR