LIMELIGHT
Received Jul 1, 2024 · Event occurred Jun 5, 2024
Report 2954354-2024-00009 · MDR key 19652586
Device
Generic name
Pulsed Light Handpiece
Manufacturer
Cutera, Inc.Product problems
- Adverse Event Without Identified Device or Use Problem
- Insufficient Device Problem Information
- Adverse Event Without Identified Device or Use Problem
- Insufficient Device Problem Information
Patient
NA · Female
- Superficial (First Degree) Burn
- Partial thickness (Second Degree) Burn
- Superficial (First Degree) Burn
- Partial thickness (Second Degree) Burn
Narrative
Description of Event or Problem
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.
Description of Event or Problem
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.