MAUDE Adverse Event Report: CYNOSURE INC. SCULPSURE

Model Number	100-7026-010
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	08/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
In this incident, patient experienced swelling and pain following a laser procedure with the sculpsure.The patient was given medication for post treatment care and had medical intervention at the emergency room.User error was involved in the event because the treatment parameters were not followed per the clinical reference guide.The device was evaluated and operated as intended within specification.Permanent injury is not expected from this event.Patient is now doing better, healing well from the event.Swelling and pain 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 for swelling/pain.

• Brand Name: SCULPSURE
• Common Device Name: SCULPSURE
• Manufacturer (Section D): CYNOSURE INC.; 5 carlisle road; westford MA 01886
• MDR Report Key: 7911697
• Report Number: 1222993-2018-00022
• Device Sequence Number: 13931659
• Product Code: PKT
• UDI-Device Identifier: 00841494100032
• UDI-Public: (01)00841494100032(11)170306
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: 09/04/2018
• 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