MAUDE Adverse Event Report: CYNOSURE LLC SCULPSURE

Model Number	100-7026-010
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device evaluation was not performed since site did not respond to the multiple requests for evaluation.The device history record confirms that the product passed and met all requirements before releasing.Labeling cautions "do not place the applicator's treatment window directly over the umbilicus.Discomfort and side effects may result." applicators must maintain full contact with skin on intended treatment area; this is not possible on the umbilicus.Site noted that patient visited a wound doctor however no additional information was provided.Burns are expected side effects from laser treatment, however due to user error this may result in permanent damage.Therefore, we are reporting out of caution.
Event or Problem Description
It was reported that a patient experienced a burn on the umbilical area following a non-invasive laser lipolysis treatment using sculpsure.

• Brand Name: SCULPSURE
• Common Device Name: SCULPSURE
• Manufacturer (Section D): CYNOSURE LLC; 5 carlisle road; westford MA 01886
• Manufacturer Contact: kelli pennie ; 5 carlisle road; westford, MA 01886 ; 9783672425
• MDR Report Key: 15156286
• Report Number: 1222993-2022-00033
• Device Sequence Number: 5048342
• Product Code: PKT
• UDI-Device Identifier: 00841494100032
• UDI-Public: (01)00841494100032(11)170329
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K182741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/03/2022

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: Other
• Device Model Number: 100-7026-010
• Device Catalogue Number: 105-7026-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male