MAUDE Adverse Event Report: CYNOSURE LLC ICON

Model Number	105-2500-000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/13/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient experienced disfigurement and skin wounds after a treatment was performed with icon max g handpiece.Site has not seen or been in contact with the patient since the last treatment on (b)(6) 2020 and have received litigation papers.
Additional Manufacturer Narrative
The device history record confirms that the product passed and met all requirements before releasing.Additional patient information was requested, but none was provided despite multiple requests from cynosure.If additional relevant data becomes available, a follow up report will be submitted.Cynosure is reporting this event out of an abundance of caution and based on the information received stating that the patient experienced adverse effects.

• Brand Name: ICON
• Common Device Name: ICON
• Manufacturer (Section D): CYNOSURE LLC; 5 carlisle road; westford MA 01886
• Manufacturer Contact: 5 carlisle road; westford, MA 01886
• MDR Report Key: 12860082
• Report Number: 1222993-2021-00045
• Device Sequence Number: 4608978
• Product Code: GEX
• UDI-Device Identifier: 00841494100018
• UDI-Public: (01)00841494100018(11)180529
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/23/2021

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: Other
• Device Model Number: 105-2500-000
• Device Catalogue Number: 105-2500-000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2018
• 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 Age: 36 YR
• Patient Sex: Female