MAUDE Adverse Event Report: CYNOSURE INC PICOSURE WORKSTATION

Model Number	100-7012-010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	02/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient was given prednisone as intervention medication during post treatment care.In addition, patient was currently taking allegra-d prior to the laser procedure.Treatment parameters were not followed per the clinical reference guide.Permanent injury is not expected as the patient has since healed, doing fine now.The device was evaluated and operated as intended within specification.Erythema is an expected side effect from laser treatments, however this event is reportable because the patient received medication for intervention use.
Event or Problem Description
Patient experienced significant erythema and histamine response following a laser procedure on hands/chest/face area.

• Brand Name: PICOSURE WORKSTATION
• Common Device Name: PICOSURE
• Manufacturer (Section D): CYNOSURE INC; 5 carlisle rd; westford MA 01886
• MDR Report Key: 7357326
• Report Number: 1222993-2018-00005
• Device Sequence Number: 13801036
• Product Code: GEX
• UDI-Device Identifier: 00841494100001
• UDI-Public: (01)00841494100001(11)170418
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K173199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/21/2018

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 Model Number: 100-7012-010
• Device Catalogue Number: 105-7012-000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2018
• Initial Report FDA Received Date: 03/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other