MAUDE Adverse Event Report: CYNOSURE LLC ELITE MD

Catalog Number	100-7001-010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	10/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient experienced a burn on the upper lip following a laser hair reduction treatment using elite md.
Additional Manufacturer Narrative
The device was evaluated and found to be operating as intended within specification.Cynosure's clinical team investigated the event and determined it was inconclusive.A full thickness burn with exposed subcutaneous tissue and significant peri-wound edema observed.Cynosure's medical director, dr.(b)(4), expects permanent scarring once healed.Per dr.(b)(4): patient can seek microneedling or non ablative fractional laser resurfacing for scar management.Root cause as to why the patient experienced burns is unknown and since there is no issues with the device and clinical investigation was inconclusive, cynosure will continue to monitor such complaints.Patient was given bacitracin ointment as preventative medication.Based on the labeling materials and risk review, burns are expected side effects from laser treatments in general, however this event is reportable because the patient experienced permanent injury.

• Brand Name: ELITE MD
• Common Device Name: ELITE MD
• 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: 20796288
• Report Number: 1222993-2024-00047
• Device Sequence Number: 20124738
• Product Code: GEX
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K141425
• 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
• Type of Report: Initial
• Report Date (Section B): 11/27/2024

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: Other
• Device Catalogue Number: 100-7001-010
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Other
• Patient Age: 67 YR
• Patient Sex: Female