MAUDE Adverse Event Report: CYNOSURE LLC VECTUS

Model Number	105-3500-000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Skin Discoloration (2074)
Date of Event	07/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Treatment took place on (b)(6) 2020.Hypopigmentation occurred but is considered an expected transient side effect.Information received 9/9/2021 that hypopigmentation is still present.The device history record confirms that the product passed and met all requirements before releasing.The device has not yet been returned for an evaluation.Burn and hypopigmentation are expected side effects from laser treatment, however this is reportable as it is likely a permanent injury.Root cause is undetermined.
Event or Problem Description
It was reported that patient experienced a burn that resulted in hypopigmentation from a treatment using vectus on (b)(6) 2020.Cynosure was notified on 9/9/2021.

• Brand Name: VECTUS
• Common Device Name: VECTUS
• Manufacturer (Section D): CYNOSURE LLC; 5 carlisle road; westford MA 01886
• MDR Report Key: 12602222
• Report Number: 1222993-2021-00039
• Device Sequence Number: 19631230
• Product Code: GEX
• UDI-Device Identifier: 00841494100124
• UDI-Public: (01)00841494100124(11)170822
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K120622
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/08/2021

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: Health Professional
• Device Model Number: 105-3500-000
• Device Catalogue Number: 105-3500-000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 10/09/2021
• 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: Other