inforMED
InjuryILY

LIMELIGHT

Received Apr 29, 2024

Report 2954354-2024-00006 · MDR key 19209963

Device

Generic name

Lamp, Infrared, Therapeutic Heating

Manufacturer

Cutera, Inc.

Product problems

  • Improper or Incorrect Procedure or Method
  • Improper or Incorrect Procedure or Method

Patient

NA · Female

  • Scar Tissue
  • Full thickness (Third Degree) Burn
  • Scar Tissue
  • Full thickness (Third Degree) Burn

Narrative

Description of Event or Problem

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.