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	Burn(s) (1757)
Date of Event	05/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no medication or intervention associated with this event.User error was involved since the operator performed the sculpsure laser treatment over an existing tattoo near the hip bone, which is cautioned against in the clinical reference guide.This resulted in the tattoo area receiving a burn that may develop into a potential scar.Per the sculpsure clinical reference guide: "when treating over a tattoo, there is an increased risk of adverse skin effects and discomfort if the applicator(s) is not in full contact with the skin" and "do not treat over scars or bony area such as hips or ribs.Discomfort or adverse skin effects may occur".As a result, there was a loss of proper contact with the skin during the treatment and prevented adequate cooling from being delivered to the treated areas.The device was not evaluated due to the user error in this incident.Burns are expected side effects from laser treatments, however this is reportable because of the potential for scarring.
Event or Problem Description
Patient experienced a burn on the flanks area 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: 7605085
• Report Number: 1222993-2018-00010
• Device Sequence Number: 283501
• Product Code: PKT
• UDI-Device Identifier: 00841494100032
• UDI-Public: (01)00841494100032(11)161209
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K171992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/15/2018

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: 100-7026-010
• Device Catalogue Number: 105-7026-000
• 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: 05/18/2018
• Initial Report FDA Received Date: 06/15/2018
• 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: 23 YR