MAUDE Adverse Event Report: CYNOSURE LLC SCULPSURE

Model Number	100-7026-010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nodule (4551)
Date of Event	06/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information was requested, but none was provided despite multiple requests to the provider.A recent device evaluation found the unit operating as intended and working within specification.The device history record confirms that the product passed and met all requirements before releasing.Per labeling, nodules are expected side effects and typically transient in nature.However, in rare cases they may be permanent.Patient received medical intervention.This event is reportable due to the medical intervention used post treatment.
Event or Problem Description
It was reported that a patient had received a sculpture treatment over a year ago and nodule is still present.Patient received medical intervention as a result of persistent nodule.

• Brand Name: SCULPSURE
• Common Device Name: SCULPSURE
• Manufacturer (Section D): CYNOSURE LLC; 5 carlisle road; westford MA 01886
• MDR Report Key: 12242693
• Report Number: 1222993-2021-00027
• Device Sequence Number: 11680107
• Product Code: PKT
• UDI-Device Identifier: 00841494100032
• UDI-Public: (01)00841494100032(11)171206
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/28/2021

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: 100-7026-010
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 07/28/2021
• 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: Required Intervention