BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAVISION

    MDR report key: 25073326 · Received May 4, 2026

    Report

    Report Number
    3012204368-2026-00001
    Event Type
    Injury
    Date Received
    May 4, 2026
    Report Date
    May 3, 2026
    Manufacturer
    AESTHETICS BIOMEDICAL, INC.
    Product Code
    GEI
    UDI-DI
    G055ABMVIVS020
    PMA / PMN Number
    K221574
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE TREATMENT RESULTS DEPICTED IN HE IMAGE PROVIDED BY THE PRACTICE WERE NOT CONSISTENT WITH THE SETTINGS REPORTED BY THE OWNER, SUGGESTING A MORE SUPERFICIAL DEPTH. THE TREATMENT RESULTS REFLECTED THE AMOUNT OF ENERGY DELIVERED WAS INAPPROPRIATELY HIGHER THAN THOSE RECOMMENDED BY THE MANUFACTURER FOR THE TARGET TISSUE. A CERTIFIED LETTER WAS SENT TO THE PRACTICE REQUIRING ADDITIONAL TRAINING FOR CONTINUED USE OF THE DEVICE.

    Description of Event or Problem · 0

    A PRACTICE CONTACTED AESTHETICS BIOMEDICAL (ABM) WITH AN IMAGE OF A PATIENT WITH HYPERTROPHIC SCARRING AND HEALING LESIONS ON THEIR ABDOMEN AFTER A RECENT ULTRAVISION TREATMENT. ABM'S CHIEF MEDICAL OFFICER (CMO) IMMEDIATELY INITIATED CONTACT WITH THE PRACTICE TO SPEAK WITH THE PRACTITIONER TO GAIN MORE KNOWLEDGE AND UNDERSTANDING ABOUT THE TREATMENT. THE CMO SPOKE WITH THE PRACTICE OWNER WHO PROVIDED INFORMATION THAT WAS CONTAINED IN THE PATIENT CHART. THE SETTINGS THAT WERE PROVIDED TO THE CMO INCLUDED POWER LEVCEL 8 (40 WATTS), 700 MS, 1 MHZ, 2 PASSES AT A DEPTH OF 3.9 MM WITH A 60-ARRAY INSULATED NEEDLE SET. THE TREATMENT PARAMETERS WERE NOT WITHIN ABM'S SUGGESTED TREATMENT GUIDELINES FOR THE TARGET TISSUE. THE CMO ATTEMPTED TO OBTAIN MORE INFORMATION, REQUESTING THAT SHE BE ABLE TO SPEAK WITH THE AESTHETICIAN WHO PERFORMED THE TREATMENT BUT WAS NOT GIVEN THE OPPORTUNITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188309 ULTRAVISION ULTRAVISION GEI AESTHETICS BIOMEDICAL, INC. G055ABMVIVS020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other TOPICAL ANESTHETIC.