VENUS VERSA

Description of Event or Problem

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.