MAUDE Adverse Event Report: CYNOSURE, LLC. PICOSURE LASER; POWERED LASER SURGICAL INSTRUMENT

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Skin Discoloration (2074); Superficial (First Degree) Burn (2685)

Event Date 06/14/2022

Event Type  Injury  

Event Description

On (b)(6) 2022 i made an appointment with skinlicious for a treatment that they recommended previously the treatment was for acne and a facial scar on my right side of face.The nurse recommended a new laser call picosure, she told me that the laser will help me to lighten up my face and help with the scars.On (b)(6) 2022 i contacted them to let them know that my face had some burned spots and had gotten darker and that i felt that i needed help with the condition that has arisen from the last picosure treatment.The owner told me that it was not their fault that why it took me 2 and a half month to reported.I told them that it was only few weeks and that i followed all her instructions.I sent them pictures and still refused to assumed responsibility and try to help me.

• Brand Name: PICOSURE LASER
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): CYNOSURE, LLC.
• MDR Report Key: 15391445
• MDR Text Key: 299746886
• Report Number: MW5111954
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Ethnicity: Hispanic