MAUDE Adverse Event Report: CYNOSURE LLC PICOSURE PRO

Catalog Number	105-7051-000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blister (4537)
Date of Event	07/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record confirms that the product passed and met all requirements before releasing.Patient was given antibiotic crème and silvadene as preventative medication.Post treatment guidelines were not followed since patient traveled to a warm climate immediately post treatment and submerged the treated area into ocean water.Site advised patient to cover the treated area with bandage and apply protective ointment, but patient did not follow post care instructions.Labeling instructs: wash the treatment area gently with soap and water.Do not soak.Failing to follow posttreatment instructions could increase risk of adverse effects.On (b)(6) 2023, patient was admitted to the hospital and given rocephin iv and clyndamicin.Due to the patient receiving medical intervention, this event is reportable.
Event or Problem Description
It was reported that patient experienced a blister on the right ankle following a laser tattoo removal treatment using picosure pro.Blister occurred 2 days post treatment.

• 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: 17669508
• Report Number: 1222993-2023-00009
• Device Sequence Number: 6325229
• Product Code: GEX
• UDI-Device Identifier: 00841494100537
• UDI-Public: (01)00841494100537(11)230127
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/01/2023

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: 08/04/2023
• Initial Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/27/2023
• 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: Other
• Patient Sex: Female