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	Burn(s) (1757)
Date of Event	11/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient experienced frosting on various body areas following a tattoo removal treatment using picosure pro.
Additional Manufacturer Narrative
The device history record confirms that the product passed and met all requirements before releasing.Cynosure clinical determined user error was involved in this event.Patient was treated with 3mm at 4.24 j/cm2, which is considered more aggressive than instructed per labeling.Treatment settings were outside the crg guidelines for skin type iii.Patient also had a different laser treatment performed prior to this treatment.Site is requesting additional training sessions.Patient was given steroid injection the day post treatment as medical intervention.Fucidin, mebo, and stem cell matrix powder were also provided as preventative medication.Burns are expected side effects from such treatments, however this event is reportable because the patient received medical intervention.

• Brand Name: PICOSURE PRO
• Common Device Name: PICOSURE PRO
• 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: 18397632
• Report Number: 1222993-2023-00018
• Device Sequence Number: 14444888
• Product Code: GEX
• UDI-Device Identifier: 00841494100537
• UDI-Public: (01)00841494100537(11)230208
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/27/2023

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2023
• Initial Report FDA Received Date: 12/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2023
• 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 Age: 26 YR
• Patient Sex: Female