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	07/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
In this incident, patient experienced a blister-burn on the abdomen area following a laser procedure with the sculpsure.However, it was determined that the burn was not due to the laser procedure, but rather from patient error.The patient had applied an ice pack directly onto the laser treated area, which resulted in a blister/burn.As a result, the patient decided to visit the er for care.There is no additional information regarding this form of intervention.The customer site indicated there were no adverse effects as a result of the laser treatment on the day of the procedure.They provided an oral antibiotic for preventative care.The treatment parameters applied in the procedure were followed per the clinical reference guide.Though this patient impact was determined to be unrelated to the effects of the laser treatment, this is being reported because the patient had medical intervention at the emergency room.
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: 7870261
• Report Number: 1222993-2018-00018
• Device Sequence Number: 1964350
• Product Code: PKT
• UDI-Device Identifier: 00841494100032
• UDI-Public: (01)00841494100032(11)170210
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/12/2018

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: 08/13/2018
• Initial Report FDA Received Date: 09/12/2018
• 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: 71 YR