MAUDE Adverse Event Report: CUTERA, INC TRUSCULPT; RADIO FREQUENCY INDUCED HEATING

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Device Issue (2379); Human Factors Issue (2948)

Patient Problems Burn(s) (1757); Erythema (1840); Injury (2348); Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)

Event Date 06/30/2017

Event Type  Injury  

Event Description

Partial thickness burn with slow wound healing.The wound is in a cosmetically sensitive area.The slow wound healing increases the risk for scar formation.The root cause of the burn is user error.The device operator treated over a contraindicated area.There is not a device performance complaint associated with the clinical event.

• Brand Name: TRUSCULPT
• Type of Device: RADIO FREQUENCY INDUCED HEATING
• Manufacturer (Section D): CUTERA, INC; 3240 bayshore blvd; brisbane CA 94005
• Manufacturer (Section G): CUTERA, INC; 3240 bayshore blvd; brisbane CA 94005
• Manufacturer Contact: renee lierly, r.n. ; 3240 bayshore blvd; brisbane, CA 94005 ; 4156575731
• MDR Report Key: 6769344
• MDR Text Key: 81894635
• Report Number: 2954354-2017-00002
• Device Sequence Number: 1
• Product Code: PBX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Outpatient Treatment Facility
• Date Manufacturer Received: 07/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other