MAUDE Adverse Event Report: CYNOSURE LLC PICOSURE PRO

Catalog Number	105-7051-000
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Hair Loss (1877)
Date of Event	02/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record confirms that the product passed and met all requirements before releasing.It has been determined that user error caused accidental pulsing to the eyebrow.A field service engineer was dispatched to the site to perform device evaluation and verified that the device meets published specifications.Patient received medical intervention as mesotherapy for hair regrowth.This is a reportable adverse event due patient receiving medical intervention.
Event or Problem Description
It was reported that patient was treated for pigmented lesions on the forehead using picosure pro.Physician who performed the treatment accidentally shot the patient's eyebrow.Shot resulted in hair loss on the eyebrows area.

• Brand Name: PICOSURE PRO
• Common Device Name: PICOSURE PRO
• 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: 17977762
• Report Number: 1222993-2023-00012
• Device Sequence Number: 3568684
• Product Code: GEX
• UDI-Device Identifier: 00841494100537
• UDI-Public: (01)00841494100537(11)220623
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K210226
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/20/2023

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 Catalogue Number: 105-7051-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2023
• Initial Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2022
• 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: Required Intervention
• Patient Sex: Female