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	Patient Problem/Medical Problem (2688)
Date of Event	01/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The treatment parameters used in the laser procedure were followed per the clinical reference guide (crg).Patient visited the emergency room (er) five weeks post treatment and was diagnosed with cellulitis.During er visit, patient was told that the fat cells and nodules were not clearing and therefore formed an abscess which developed into cellulitis.Nodules are an expected side effect from sculpsure treatment and expected to be transient when post-treatment instructions are followed.It is unknown if the patient followed the post-care treatment per labeling.Antibiotics were given as preventative medication.A recent device evaluation was performed and there was no indication of device malfunction.The device history record confirms that the product passed and met all requirements before releasing.Though the patient experienced an expected transient side effect from a sculpsure laser treatment, this event is reportable because the patient was diagnosed with cellulitis.
Event or Problem Description
It was reported that a patient was diagnosed with cellulitis following a noninvasive laser lipolysis treatment using sculpsure.

• Brand Name: SCULPSURE
• Common Device Name: SCULPSURE
• Manufacturer (Section D): CYNOSURE LLC; 5 carlisle road; westford, ma
• MDR Report Key: 9866468
• Report Number: 1222993-2020-00012
• Device Sequence Number: 2952488
• Product Code: PKT
• UDI-Device Identifier: 00841494100032
• UDI-Public: (01)00841494100032(11)181213
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K182741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/23/2020

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 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: 02/24/2020
• Initial Report FDA Received Date: 03/23/2020
• 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: 74 YR