MAUDE Adverse Event Report: CYNOSURE INC. ICON

Model Number	105-2500-000
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	01/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
In this incident, patient experienced a burn and erythema on the bikini area following a hair removal procedure with the icon's max r ipl handpiece.This resulted in the patient having medical intervention at a burn clinic and receiving medication cream for post treatment care.It was determined that the treatment did not follow the clinical reference guidelines, therefore user error was involved.In addition, the operator performed the procedure too close to an existing tattoo.The clinical reference guide was not followed as it cautions: "caution: avoid treating within one inch or directly over any tattoo or permanent cosmetic makeup/tattoos.Doing so can result in skin damage or ink color changes".Patient is now doing well from the incident.Burns/erythema are expected side effects from such hair removal treatments, however this event is reportable because the patient had medical intervention.
Event or Problem Description
Patient had medical intervention following a hair removal procedure.

• Brand Name: ICON
• Common Device Name: ICON
• Manufacturer (Section D): CYNOSURE INC.; 5 carlisle road; westford MA 01886
• MDR Report Key: 8362901
• Report Number: 1222993-2019-00004
• Device Sequence Number: 1923268
• Product Code: PKT
• UDI-Device Identifier: 00841494100018
• UDI-Public: (01)00841494100018(11)171116
• 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
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 02/22/2019

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: R105-2500-000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 02/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 27 YR