MAUDE Adverse Event Report: CYNOSURE LLC PICOSURE

Catalog Number	100-7012-010
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Skin Infection (4544)
Date of Event	04/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient developed an infection on the leg 4 days post treatment using picosure.It is likely that patient did not follow post treatment instructions.
Additional Manufacturer Narrative
The device history record confirms that the product passed and met all requirements before releasing.Cynosure's clinical team investigated the event and confirmed user error and patient error was involved.Per cynosure clinical: the treatment settings used were aggressive for skin type iv.Test spots were not performed prior to treatment.Site relayed that patient did not follow post care instructions which likely caused infection experienced.Appropriate protocol was dispatched to the site.Patient applied neosporin and hydrogen peroxide at their own discretion.Patient was prescribed two rounds of antibiotic as medical intervention.Patient was concerned about dent on their skin.Cynosure medical director was not able to observe a dent in the tissue but recommends microneedling once area is healed.This event is reportable since patient received medical intervention.

• Brand Name: PICOSURE
• Common Device Name: PICOSURE
• 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: 19627282
• Report Number: 1222993-2024-00031
• Device Sequence Number: 7400549
• Product Code: GEX
• UDI-Device Identifier: 00841494100001
• UDI-Public: (01)00841494100001(11)190225
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 06/27/2024

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: 100-7012-010
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/25/2019
• 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: 49 YR
• Patient Sex: Male