MAUDE Adverse Event Report: CYNOSURE LLC REVLITE SI

Model Number	661-1000
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	03/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient noticed a dark spot on her tooth following a rejuvenation treatment using revlite si.
Additional Manufacturer Narrative
The device history record confirms that the product passed and met all requirements before releasing.User error was involved since site performed a treatment that was not listed within labeling.This event is reportable because the patient received medical intervention to remove the dark spot.The report is delayed due to connectivity issues with webtrader.Fda was notified on 1apr22 of this issue along with a copy of the report.

• Brand Name: REVLITE SI
• Common Device Name: REVLITE SI
• Manufacturer (Section D): CYNOSURE LLC; 5 carlisle rd; westford MA 01886
• Manufacturer Contact: kelli pennie ; 5 carlisle rd; westford, MA 01886 ; 9783672425
• MDR Report Key: 13997980
• Report Number: 1222993-2022-00013
• Device Sequence Number: 20050010
• Product Code: GEX
• UDI-Device Identifier: 00841494100223
• UDI-Public: (01)00841494100223(11)171214
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K133254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/04/2022

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: 661-1000
• Device Catalogue Number: 661-1000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2017
• 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: 22 YR
• Patient Sex: Female