BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCURE LASER SYSTEM

    MDR report key: 19680873 · Received July 5, 2024

    Report

    Report Number
    3017786046-2024-00002
    Event Type
    Injury
    Date Received
    July 5, 2024
    Date of Event
    October 26, 2023
    Report Date
    July 16, 2024
    Manufacturer
    ACCURE ACNE, INC.
    Product Code
    GEX
    PMA / PMN Number
    K222109
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS OBTAINED FROM THE TREATING PHYSICIAN, WHO IS A BOARD-CERTIFIED DERMATOLOGIST. THEY STATED THAT THE MEDICAL INTERVENTION WAS BEING PROVIDED TO FACILITATE THE PATIENT'S HEALING PROCESS. WITHOUT THE MEDICAL INTERVENTION THE PHYSICIAN STATED THAT THE NATURAL HEALING PROCESS WOULD HAVE OCCURRED OVER TIME AND NOT RESULT IN A PERMANENT SEQUELA. WITH THIS ADDITIONAL INFORMATION, THIS COMPLAINT DOES NOT MEET THE DEFINITION OF A SERIOUS INJURY (PERMANENT DAMAGE TO A BODY STRUCTURE).

    Additional Manufacturer Narrative · 0

    EXAMINATION BY ACCURE ENGINEERING LED TO THE CONCLUSION THAT INCORRECT SETTINGS WERE USED FOR THE TREATMENT. THE DOCTOR USED A POWER SETTING THAT WAS 11W HIGHER THAN WHAT IS RECOMMENDED IN THE ACCURE LASER SYSTEM USER MANUAL FOR THE TREATMENT HE WAS PERFORMING. SYSTEM LOG ANALYSIS BY ACCURE ENGINEERING LED TO THE OBSERVATION THAT SKIN OVERTEMPERATURE ERRORS, INTENDED TO ALERT A PROVIDER WHEN EXCESSIVE POWER IS BEING APPLIED, TRIGGERED 32 TIMES DURING THE TREATMENT. EACH OF THESE ERRORS WOULD HAVE REQUIRED THE DOCTOR TO PRESS TWO BUTTONS ON THE SCREEN, ONE ACKNOWLEDGING THE ERROR AND THEN THE NEXT TO CONTINUE TREATING AFTER EACH INSTANCE OF THE ERROR.

    Description of Event or Problem · 0

    DURING A ROUTINE SITE VISIT ON (B)(6) 2024, ACCURE CLINICAL TRAINING STAFF LEARNED OF AN INCIDENT THAT HAD OCCURRED OVER SIX MONTHS AGO. A TREATMENT RESULTED IN SIGNIFICANT SCARRING TO A PATIENT FOR WHICH THE DOCTOR HAS BEEN PERFORMING A NUMBER OF SUBSEQUENT TREATMENTS TO TRY TO RESOLVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1132953 ACCURE LASER SYSTEM ACNE LASER GEX ACCURE ACNE, INC. PFMS00004

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention