MAUDE Adverse Event Report: CUTERA, INC. LIMELIGHT; PULSED LIGHT HANDPIECE

Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)
Date of Event	06/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The limelight pulsed light handpiece was utilized in a medical procedure treating the anterior aspects of both the upper and lower legs, bilaterally.The primary objective of this intervention was the mitigation of benign pigmented lesions.Post procedure, the patient exhibited symptoms of superficial epidermal and superficial partial thickness burns.These dermal injuries are currently undergoing a treatment regimen that includes "stem cell treatment", in conjunction with the application of topical ointments eucerin and aquaphor.The medical institution has not responded to cutera's requests for specific details pertaining to the patient, the treatment protocol, and the subsequent outcome.There is not a device performance complaint associated with this clinical case.
Event or Problem Description
This is a follow-up to the initial emdr filed on 01-jul-2024.As reported initially, the limelight pulsed light handpiece was utilized in a medical procedure on (b)(6) 2024 to treat the anterior aspects of both the upper and lower legs, bilaterally.The primary objective of this intervention was the mitigation of benign pigmented lesions.Post procedure, the patient exhibited symptoms of superficial epidermal and superficial partial thickness burns.The dermal injuries were treated with stem cell treatment, in conjunction with the application of topical ointments eucerin and aquaphor.The medical institution has not responded to cutera's requests for specific details pertaining to the patient, the treatment protocol, and the subsequent outcome.Since the initial emdr, the device was evaluated by a cutera fse and was found to be within specification.

• Brand Name: LIMELIGHT
• Common Device Name: PULSED LIGHT HANDPIECE
• 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: 19652586
• Report Number: 2954354-2024-00009
• Device Sequence Number: 6549634
• Product Code: ILY
• UDI-Device Identifier: 00816722022110
• UDI-Public: 00816722022110
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K050047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2024

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
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Female
• Patient Race: White