BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCENT

    MDR report key: 8404853 · Received March 8, 2019

    Report

    Report Number
    3004167969-2019-00009
    Event Type
    Injury
    Date Received
    March 8, 2019
    Date of Event
    January 22, 2019
    Report Date
    February 6, 2019
    Manufacturer
    ALMA LASERS LTD
    Product Code
    IMI
    UDI-DI
    17290110120228
    PMA / PMN Number
    K160075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION LETTER E2013012 ALMA LTD. (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF ALMA, INC. (IMPORTER). SECTION H3: ALMA INC. (IMPORTER) HAS MADE AN ATTEMPT FOR DEVICE RETRIEVAL AND IS IN THE PROCESS OF MAKING FURTHER ATTEMPTS TO REQUEST THE DEVICE BACK FOR EVALUATION. ALMA LTD. CLINICAL REACHED OUT TO AN INDEPENDENT MEDICAL EXPERT FOR THE MEDICAL ASSESSMENT. AS PER THEIR ASSESSMENT, THE PATIENT MAY HAVE HAD DEEP SECOND DEGREE BURNS. (B)(4) HAS MADE MULTIPLE ATTEMPTS TO REQUEST PATIENT FOLLOW-UP CONDITION; NO UPDATES ARE AVAILABLE. ALMA LTD. CLINICAL HAS THEREFORE, DETERMINED THIS EVENT TO BE REPORTABLE AND IS SUBMITTING THIS REPORT TO THE FDA IN GOOD FAITH EFFORTS. SHOULD ANY INFORMATION BECOME AVAILABLE, ALMA WILL SUBMIT SUPPLEMENTAL REPORT WITHIN THE FDA PUBLISHED TIMELINES.

    Description of Event or Problem · 0

    THE SUSPECTED DEVICE WAS USED ON THE PATIENT'S ABDOMEN. AS PER THE FACILITY, THE PATIENT REPORTED SHE HAS SUSTAINED A SMALL BURN 1 INCH TO THE RIGHT OF HER BELLY BUTTON. THE PATIENT CALLED IN TO REPORT THIS BURN TWO WEEKS AFTER THE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198588 ACCENT MEDICAL LASER IMI ALMA LASERS LTD RF 17290110120228

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Disability