MAUDE Adverse Event Report: VENUS CONCEPT LTD VENUS VERSA

Model Number	VE102407
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	02/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
15, february 2023: email sent to clinical reporting a burn from hair removal treatment.Trainer emailed to gather additional information.In an effort to get more information about the severity of the burn on the legs, two email correspondence was sent on the 15 feb 2023 and 21 feb 2023, but no avail.One phone call made trying to get a hold of the clinic, call keeps dropping; no answer.
Additional Manufacturer Narrative
Complaint/investigation summary: feedback details (description of complaint).15, february 2023: email sent to clinical reporting a burn from hair removal treatment.Trainer emailed to gather additional information.(b)(6).Evaluation for investigation: part/lot or serial numbers: ve102407/ 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 versa user manual was reviewed.Damage to natural skin texture (crust, blister, burn) was a known side effects by labeling.Risk assessment review: versa risk analysis report rd-ve-04 is covered in items.1,.2,.3,.4,.8, & 1 at different causes and hazards.In this case the reported brown marks are known side effects post treatment.Patient outcome: in an effort to get more information about the severity of the burn on the legs, two email correspondence was sent, but no avail.One phone call made trying to get a hold of the clinic, call keeps dropping; no answer.With the information available, there is no failure, or no patient injury can be established.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.If new information come available, this complaint will be re-opened and re-assessed.

• Brand Name: VENUS VERSA
• Common Device Name: VERSA
• Manufacturer (Section D): VENUS CONCEPT LTD; hayozma street, bld. 6; yokneam, 20692 03; IS 2069203
• Manufacturer (Section G): VENUS CONCEPT INC; 1800 bering drive; san jose CA 95112
• Manufacturer Contact: sylvia wilkinson ; 1800 bering drive; sanjose, CA 95112 ; 8889070115
• MDR Report Key: 16673531
• Report Number: 3006515340-2023-00005
• Device Sequence Number: 6379520
• Product Code: ONF
• UDI-Device Identifier: 07290016540383
• UDI-Public: (01)07290016540383
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K153717
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• 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): 03/08/2023

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: VE102407
• Device Catalogue Number: VE102407
• 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: 02/15/2023
• Initial Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2021
• 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 Sex: Unknown