MAUDE Adverse Event Report: VENUS CONCEPT INC. VENUS BLISS; Laser assisted lipolysis

Catalog Number	BL000001
Medical Device Problem Code	Flare or Flash (2942)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint evaluation summary report attached (file: (b)(4) power cord fire).
Event or Problem Description
Venus bliss power and cord got on fire.

• Brand Name: VENUS BLISS
• Common Device Name: Laser assisted lipolysis
• Manufacturer (Section D): VENUS CONCEPT INC.; 1800 bering drive; san jose CA 95112
• Manufacturer (Section G): VENUS CONCEPT, INC.; 1800 bering drive; san jose 95112
• Manufacturer Contact: sylvia wilkinson ; 1800 bering drive; san jose, CA 95112 ; 8889070115
• MDR Report Key: 18947098
• Report Number: 3006515340-2024-00001
• Device Sequence Number: 12775523
• Product Code: ORK
• UDI-Device Identifier: 07290016541281
• UDI-Public: (01)07290016541281
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K190743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: BL000001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2020
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown