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	12/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
In this incident, patient experienced a blister on the abdomen - 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 creases in the skin/uneven tissue upon the flanks.The clinical reference guide was not followed as it cautions: "do not treat over areas of deep, thick skin folds where the applicator may not cool the area adequately.Discomfort and adverse skin effects may result." the patient sought medical intervention at a burn center where the wound was debrided and received enzymatic medication cream.Blisters are expected side effects from laser treatments, however this event 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: 8304615
• Report Number: 1222993-2019-00002
• Device Sequence Number: 18847712
• Product Code: PKT
• UDI-Device Identifier: 00841494100032
• UDI-Public: (01)00841494100032(11)171104
• 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: consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/05/2019

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 02/05/2019
• 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: 40 YR