MAUDE Adverse Event Report: CYNOSURE LLC PICOSURE PRO

Catalog Number	105-7051-000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	06/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical determined the event to be inconclusive.Settings used were aggressive, but within normal range.Patient was prescribed silver sulfadiazine topical 3 times daily.Scab was formed and removed by debridement.The device history record confirms that the product passed and met all requirements before releasing.Burn was examined by cynosure medical director who confirmed scarring.A service evaluation has not yet been completed.When the device has been returned for evaluation, the outcome of the investigation will be updated as needed.Burns are expected side effects from such treatments; however this event is reportable because scarring is considered a serious permanent injury and patient received intervention.
Event or Problem Description
It was reported that patient experienced blister on the upper arm following a laser tattoo removal treatment using picosure pro.

• 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: 19666562
• Report Number: 1222993-2024-00036
• Device Sequence Number: 15179555
• Product Code: GEX
• UDI-Device Identifier: 00841494100537
• UDI-Public: (01)00841494100537(11)220301
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/03/2024

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: 105-7051-000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/29/2022
• 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: Male