MAUDE Adverse Event Report: VENUS CONCEPT INC. VENUS CONCEPT; VENUS BLISS

Model Number	BL000001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	03/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a treatment session with the venus bliss, a burn to the patient was observed.The medical intervention as a result of this event was used the otc burn ointment.There was no hospitalization required.The patient recovered but left with a scar.

• Brand Name: VENUS CONCEPT
• Common Device Name: VENUS BLISS
• Manufacturer (Section D): VENUS CONCEPT INC.; 1800 bering drive,; san jose CA 95112
• Manufacturer Contact: rehan zariwala ; 1800 bering drive,; san jose, CA 95112
• MDR Report Key: 24813288
• Report Number: 3006515340-2026-00004
• Device Sequence Number: 15841800
• Product Code: PKT
• UDI-Device Identifier: 00810060830444
• UDI-Public: (01)00810060830444
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/29/2026

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: BL000001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/08/2026
• 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
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic