MAUDE Adverse Event Report: CYNOSURE LLC SCULPSURE

Catalog Number	105-7026-000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Swelling/ Edema (4577)
Date of Event	02/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient experienced erythema and edema on the outer thigh area following a noninvasive laser lipolysis treatment using sculpsure.Patient also reports that the treatment area is tender to touch 6 days post treatment.
Additional Manufacturer Narrative
The device history record confirms that the product passed and met all requirements before releasing.Patient has a history diagnosis of scleroderma, an autoimmune disease that causes inflammation and fibrosis in the skin and other areas of the body.Cynosure's clinical team was unable to determine if patient's autoimmune disease contributed to symptoms experienced.Root cause is unknown and since there is no issues with the device production records and clinical investigation was inconclusive, cynosure will continue to monitor such complaints.Based on the labeling materials and risk review, erythema and edema are expected side effects from such treatments.Patient was prescribed prednisone as intervention.This is a reportable adverse event due to patient receiving medical intervention.

• Brand Name: SCULPSURE
• Common Device Name: SCULPSURE
• Manufacturer (Section D): CYNOSURE LLC; 5 carlisle road; westford MA 01886
• Manufacturer Contact: nirav desai ; 5 carlisle road; westford, MA 01886 ; 9783940763
• MDR Report Key: 18958597
• Report Number: 1222993-2024-00011
• Device Sequence Number: 4540804
• Product Code: PKT
• UDI-Device Identifier: 00841494100032
• UDI-Public: (01)00841494100032(11)190716
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K210226
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/22/2024

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 Catalogue Number: 105-7026-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2024
• Initial Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2019
• 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: Female