MAUDE Adverse Event Report: CYNOSURE PICOSURE

Model Number	100-7012-010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Scarring (2061)
Date of Event	09/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer site stated that the appearance of the scar was a result of the patient's poor post treatment care and the location of the tattoo being inside the crease of the arm area.The friction caused by the movement of the arm led to the formation of the keloid scar.The customer site believes that the scar's formation was not related to the laser treatment.There was no additional information made available regarding this event despite multiple requests for patient-treatment details made by cynosure.The device was evaluated and operated as it was intended.Technician did perform routine system maintenance on the device as part of the evaluation process.Since the patient experienced a scarring injury on the arm, this a reportable event.
Event or Problem Description
Patient developed a keloid scar on the arm following a tattoo removal laser procedure.

• Brand Name: PICOSURE
• Common Device Name: PICOSURE
• Manufacturer (Section D): CYNOSURE; 5 carlisle road; westford MA 01886
• MDR Report Key: 8153391
• Report Number: 1222993-2018-00032
• Device Sequence Number: 295203
• Product Code: GEX
• UDI-Device Identifier: 00841494100001
• UDI-Public: (01)00841494100001(11)171215
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K173199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/11/2018

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: No Information
• Device Model Number: 100-7012-010
• Device Catalogue Number: 105-7012-000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2018
• Initial Report FDA Received Date: 12/11/2018
• 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