BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACLEAR

    MDR report key: 23165852 · Received September 29, 2025

    Report

    Report Number
    3021550489-2025-00005
    Event Type
    Injury
    Date Received
    September 29, 2025
    Date of Event
    August 14, 2025
    Report Date
    September 26, 2025
    Manufacturer
    ACCLARO CORPORATION
    Product Code
    GEX
    PMA / PMN Number
    K210847
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER DID NOT PROVIDE DEVICE SERIAL NUMBER OR ADDRESS WHERE TREATMENT OCCURED.

    Description of Event or Problem · 0

    A PATIENT IN KOREA WAS TREATED USING ULTRACLEAR FOR HYPERTROPHIC SCARS ON BOTH ARMS. TWO TREATMENTS WERE PERFORMED. THE FIRST ON (B)(6) 2025 WITH NO INCIDENT, THE SECOND ON (B)(6) 2025. AFTER THE SECOND TREATMENT THE PATIENT BEGAN TO DEVELOP LESIONS WHERE TREATMENT HAD BEEN ADMINISTERED. THE TREATING PHYSICIAN INITIALLY BELIEVED THE LESIONS TO BE A RESULT OF IMPETIGO. THE PHYSICIAN ORDERED ANTIBIOTICS AND AN ESCHARECTOMY. COMMUNICATION WITH THE PHYSICIAN REVEALED THE PATIENT HAD A HISTORY OF HERPES LABIALIS. HERPES VIRUSES ARE A KNOWN CONTRAINDICAITON TO ULTRACLEAR TREATMENT LISTED IN THE IFU. THE OBSERVED LESIONS ARE CONSISTENT WITH THE EXPECTED RESULTS OF ULTRACLEAR TREATMENT ON PATIENTS WITH A HISTORY OF HERPES VIRUSES USING NO PHROPHYLACTIC ANTIVIRALS. THE PATIENT IS EXPECTED TO MAKE A FULL RECOVERY WITH TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1943742 ULTRACLEAR FRACTIONAL MID-IR LASER GEX ACCLARO CORPORATION AS-WB-00055

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female Required Intervention