MAUDE Adverse Event Report: CUTERA, INC. LIMELIGHT; Lamp, infrared, therapeutic heating

Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Scar Tissue (2060); Full thickness (Third Degree) Burn (2696)
Type of Reportable Event	Serious Injury
Event or Problem Description
Incident report: burn following limelight procedure source: clinic in japan.Patient information: adult female.Burn dimensions: 3 cm x 1 cm.Burn care: information not provided.Burn outcome: burn healed by epidermal regeneration resulting in a depressed scar (3 cm x 1 cm).Affected area: face.Procedure: limelight.Indication for treatment: not provided.Patient age: not specified.Procedure date: not specified.The clinic reported an adverse event in which the patient experienced a burn on the face after undergoing a limelight procedure.Further details regarding the indication for treatment, patient age, and procedure date were not provided by the clinic.There is not a device performance complaint associated with the clinical case.The patient underwent a series of 90 energy pulses directed at the facial area.A burn occurred following a single pulse, resulting in a burn shaped like the cooling/treatment window.This suggests that the operator momentarily lost contact between the skin and the cooling/treatment window during energy delivery.Such loss of contact compromises effective cooling of the underlying tissue during energy administration.

• Brand Name: LIMELIGHT
• Common Device Name: Lamp, infrared, therapeutic 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: julia brown ; 3240 bayshore blvd.; brisbane, CA 94005 ; 4156575575
• MDR Report Key: 19209963
• Report Number: 2954354-2024-00006
• Device Sequence Number: 15480122
• Product Code: ILY
• UDI-Device Identifier: 00816722022110
• UDI-Public: 00816722022110
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/29/2024

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: 04/05/2024
• Initial Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Disability
• Patient Sex: Female
• Patient Race: Asian