MAUDE Adverse Event Report: CYNOSURE LLC SCULPSURE

Model Number	100-7026-010
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Scar Tissue (2060)
Date of Event	06/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Burns are an expected side effect from such treatment.Patient's burn became a blister that had healed but left a scar.There was a tissue fold/pinched tissue under the applicator that contributed to the patient sustaining a burn.Treating over a tissue fold/pinched tissue is not recommended.The clinical reference guide 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 device history record confirms that the product was in specification when manufactured.This is a reportable adverse event due to the permanent scarring.
Event or Problem Description
It was reported that a patient experienced a burn on the flank area following a noninvasive laser lipolysis treatment using sculpture.Burn was observed in the patient's skin fold.

• Brand Name: SCULPSURE
• Common Device Name: SCULPSURE
• Manufacturer (Section D): CYNOSURE LLC; 5 carlisle road; westford MA 01886
• MDR Report Key: 12242276
• Report Number: 1222993-2021-00026
• Device Sequence Number: 17061471
• Product Code: PKT
• UDI-Device Identifier: 00841494100032
• UDI-Public: (01)00841494100032(11)170306
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,foreign
• 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: Other
• Device Model Number: 100-7026-010
• Device Catalogue Number: 100-7026-010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2021
• 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: Disability