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 Codes	Burn(s) (1757); Patient Problem/Medical Problem (2688)
Date of Event	12/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Following the laser procedure, patient experienced a burn/blister which resulted in the patient having medical intervention at the emergency room and consulting with a physician.Patient was given aquaphor ointment for post care treatment care.The treatment parameters used in the laser procedure were followed per the clinical reference guide.The patient's treated area is now showing improvement since the laser procedure.The device was evaluated and determined to be operating as intended within specification.Burns/blisters are expected side effects from a laser procedure, however since the patient had medical intervention, this is a reportable event.
Event or Problem Description
Patient had a burn/blister on the abdomen from a laser procedure.

• Brand Name: SCULPSURE
• Common Device Name: SCULPSURE
• Manufacturer (Section D): CYNOSURE INC; 5 carlisle rd; westford MA 01886
• MDR Report Key: 7169546
• Report Number: 1222993-2018-00001
• Device Sequence Number: 1455656
• Product Code: PKT
• UDI-Device Identifier: 00841494100032
• UDI-Public: (01)00841494100032(11)161004
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/05/2018

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: 100-7026-010
• 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: 12/08/2017
• Initial Report FDA Received Date: 01/05/2018
• 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