BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENUS BLISS MAX

    MDR report key: 23649967 · Received November 25, 2025

    Report

    Report Number
    3006515340-2025-00002
    Event Type
    Injury
    Date Received
    November 25, 2025
    Date of Event
    September 13, 2025
    Report Date
    November 25, 2025
    Manufacturer
    VENUS CONCEPT INC
    Product Code
    PKT
    PMA / PMN Number
    K220592
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ANALYSIS: VENUS CONCEPT WAS NOTIFIED ON 10/29/2025, EVENT DESCRIPTION: DURING A TREATMENT SESSION, THE PATIENT SUSTAINED A BURN. PATIENT REQUIRED MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. PATIENT HAD A DOCTOR EXAMINE AND PRESCRIBED MEDICATION (AQUAPHOR) TO THE AFFECTED AREA AS APART OF IMMEDIATE CARE. THE PATIENT LATER FULLY RECOVERED; HOWEVER, A SCAR REMAINED AT THE BURN SITE. PHOTOS SUBMITTED BY THE PATIENT CONFIRMED THE PRESENCE OF THE BURN. LABELING: PER VENUS BLISSMAX USER MANUAL, UMBX0001 REV G. WARNING: ADVERSE EFFECT: SKIN BURN MAY OCCUR IF THE OPERATOR DOES NOT FOLLOW INSTRUCTIONS, E.G., HOLDING THE APPLICATOR TOO LONG ON THE SAME SPOTS, NOT APPLYING SUFFICIENT AMOUNT OF GLYCERIN COUPLING MEDIUM (GLIDE) TO THE TREATMENT AREA OR SELECTING INAPPROPRIATE PARAMETERS. A.11. POST-TREATMENT INFORMATION AFTER A VENUS BLISSMAX TREATMENT, SOME PATIENTS MAY EXPERIENCE SOME MILD SIDE EFFECTS, INCLUDING BUT NOT LIMITED TO: REDNESS/ERYTHEMA, SWELLING/EDEMA, NODULES OR AREAS OF FIRMNESS, SKIN HARDNESS, BRUISING, TENDERNESS, DAMAGE TO NATURAL SKIN (CRUST, BLISTER, BURN), WITH POSSIBLE SECONDARY DERIVED ADVERSE EVENT. C.11. POST-TREATMENT INFORMATION: AFTER A FLEXMAX TREATMENT, SOME PATIENTS MAY EXPERIENCE MILD POST-TREATMENT EFFECTS, FOR UP TO 48 HOURS, INCLUDING BUT NOT LIMITED TO: SKIN IRRITATION AND BURNS BENEATH THE ELECTRODES, WHICH HAVE BEEN REPORTED WITH THE USE OF POWERED MUSCLE STIMULATORS. CONCLUSION: BASED ON THE PRELIMINARY ASSESSMENT COMPLETED BY VENUS CONCEPT INC. THERE HAVE BEEN NO REOCCURRENCE OR SYSTEMIC ISSUES. DEVICE HISTORY RECORD (DHR) HAS BEEN REVIEWED AND FOUND COMPLY WITH ALL SPECIFICATIONS. FINAL TEST SUCCESSFULLY PASSED AND NO DEVIATIONS WERE FOUND. CAUSE OF THE EVENT: THE CAUSE OF THE EVENT IS USER ERROR. RESOLUTION ACTIVITY: RETRAINING OF THE ACCOUNT WAS CONDUCTED DUE TO THE BURN. THIS EVEN WAS NOT RELATED TO DEVICE MALFUNCTION BUT USER ERROR IN CLIENT SELECTION AND BELT PLACEMENT.

    Description of Event or Problem · 0

    VENUS CONCEPT WAS NOTIFIED BY THE FDA (MW5176753) ON 10/29/2025 THE FOLLOWING: "I WAS ON THE 2ND OF 3 SESSIONS ON THE VENUS BLISS LASER LIPO (LIPOLYSIS) AT (B)(6) BUT THIS TIME WITH A DIFFERENT TECHNICIAN AND SUFFERED A TERRIBLE BURN. ITS FDA CLEARED AND ADVERTISED ON THEIR SITE AS "THE TREATMENT IS SAFE, AND COMFORTABLE, AND REQUIRES NO RECOVERY TIME. VENUS BLISS MAX/EMS (ELECTRICAL MUSCLE STIMULATION) CAN HELP YOU ACHIEVE A MORE TONED AND YOUTHFUL APPEARANCE WITHOUT SURGERY OR DOWNTIME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2137389 VENUS BLISS MAX BLISS MAX PKT VENUS CONCEPT INC BLMX0001

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention