MAUDE Adverse Event Report: VENUS CONCEPT INC. VENUS VELOCITY

Model Number	VL000001
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	02/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint/investigation summary: feedback details (description of complaint): received an email from account today, regarding wanting my professional advise" on how to get rid of a burn mark from her customer's leg.Evaluation for investigation: part/lot or serial numbers: vl000001/ serial #: (b)(4).Dhr review: none - there is no device failure.The reported issue is a clinical event related to the procedure.User manual review: venus velocity user manual was reviewed.Damage to natural skin texture (crust, blister, burn) was a known side effects by labeling.Risk assessment review : velocity risk analysis report rd-vl-006 is covered in items 1.6, 2.1, 2.2, 2.3, 2.12, 2.13, 2.14, 3.1, 3.2, 3.3, 3.4, 3.5, 4.4, 5.3, & 7.1 at different causes and hazards.In this case the reported burn marks from customer legs is a known side effects post treatment.Patient outcome: there is no failure and no patient injury.The reported event based on the labeling is a known side effect post treatment.Investigation results (conclusion): based on the review of the reported patient outcome, labeling and risk analysis, that the reported adverse event by the patient consistent to the known side effects by labeling.
Event or Problem Description
Received an email from account regarding wanting my professional advise on how to get rid of a burn mark from her customer's leg.

• Brand Name: VENUS VELOCITY
• Common Device Name: VELOCITY
• Manufacturer (Section D): VENUS CONCEPT INC.; 1800 bering drive; san jose CA 95112
• Manufacturer Contact: sylvia wilkinson ; 1800 bering drive; san jose, CA 95112 ; 8889070115
• MDR Report Key: 16723389
• Report Number: 3006515340-2023-00004
• Device Sequence Number: 17939760
• Product Code: GEX
• UDI-Device Identifier: 07290016540628
• UDI-Public: (01)07290016540628
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K162765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2023

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: VL000001
• Device Catalogue Number: VL000001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2018
• 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: 39 YR
• Patient Sex: Female
• Patient Race: White