MAUDE Adverse Event Report: CYNOSURE LLC ICON; MAXG HP, ICON

Catalog Number	2520A-G046
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	05/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record confirms that the product passed and met all requirements before releasing.The device was evaluated and found to be operating as intended within specification.Cynosure clinical team reviewed the information and determined potential user error was involved in this event.Operator used an aggressive pulse width and performed 2 passes with 50% overlap.The combination of aggressive pulse width and too much overlap on multiple passes contributed to the swelling which is an expected side effect in some cases.This is a reportable adverse event due to patient receiving medical intervention.
Event or Problem Description
It was reported that a patient experienced swelling on the face following a treatment using icon max g handpiece.

• Brand Name: ICON
• Common Device Name: MAXG HP, ICON
• Manufacturer (Section D): CYNOSURE LLC; 5 carlisle road; westford MA 01886
• Manufacturer Contact: nirav desai ; 5 carlisle road; westford, MA 01886 ; 9783940763
• MDR Report Key: 18870958
• Report Number: 1222993-2024-00008
• Device Sequence Number: 20817024
• Product Code: GEX
• UDI-Device Identifier: 00841494100278
• UDI-Public: (01)00841494100278(11)170531
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 03/08/2024

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 Catalogue Number: 2520A-G046
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2017
• 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
• Patient Sex: Female