MAUDE Adverse Event Report: CYNOSURE INC. SCULPSURE

Model Number	100-7026-010
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	08/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
In this incident, patient experienced a blister on the flanks area following a laser procedure with the sculpsure.User error was involved in this incident since it was also determined that the treatment was performed over stretchmarks.The clinical reference guide was not followed as it cautions: "never treat over open areas, rashes, healing wounds or any skin that is not intact.Document any stretch marks, scars, prominent vessels, moles, tattoos, or skin irregularities." the patient sought medical intervention at urgent care.There was no medication prescribed to the patient in this event.The device was evaluated and found to be operating as intended within specification.Blisters are expected side effects from laser treatments, however this is reportable because the patient had medical intervention.
Event or Problem Description
Patient had medical intervention following a laser procedure.

• Brand Name: SCULPSURE
• Common Device Name: SCULPSURE
• Manufacturer (Section D): CYNOSURE INC.; 5 carlisle road; westford MA 01886
• MDR Report Key: 7911676
• Report Number: 1222993-2018-00021
• Device Sequence Number: 1936610
• Product Code: PKT
• UDI-Device Identifier: 00841494100032
• UDI-Public: (01)00841494100032(11)170329
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K171992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/26/2018

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: No Information
• Device Model Number: 100-7026-010
• Device Catalogue Number: 105-7026-000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 09/26/2018
• 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
• Patient Age: 30 YR