MAUDE Adverse Event Report: CYNOSURE LLC ICON

Model Number	105-2500-000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Scar Tissue (2060); Skin Discoloration (2074)
Date of Event	09/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient presented with a keloid scar 6 months post treatment.Hypopigmentation also occurred however this is an expected side effect from such treatment and is expected to be transient.The device was evaluated and confirmed to be operating as intended and within specification.The device history record confirms that the product passed and met all requirements before releasing.This is a reportable adverse event due to the permanent injury resulting from scarring.
Event or Problem Description
Patient reported permanent injury of a scar following a treatment using icon max g handpiece.

• Brand Name: ICON
• Common Device Name: ICON
• Manufacturer (Section D): CYNOSURE LLC; 5 carlisle road; westford MA 01886
• Manufacturer Contact: susan yun ; 5 carlisle road; westford, MA 01886 ; 9783672450
• MDR Report Key: 16768229
• Report Number: 1222993-2023-00003
• Device Sequence Number: 19617961
• Product Code: GEX
• UDI-Device Identifier: 00841494100018
• UDI-Public: (01)00841494100018(11)190703
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K142376
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 04/19/2023

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
• Device Model Number: 105-2500-000
• Device Catalogue Number: 105-2500-000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2019
• 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