BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONY XL

    MDR report key: 8362654 · Received February 22, 2019

    Report

    Report Number
    3004167969-2019-00008
    Event Type
    Injury
    Date Received
    February 22, 2019
    Date of Event
    January 22, 2019
    Report Date
    January 23, 2019
    Manufacturer
    ALMA LASERS LTD
    Product Code
    GEX
    UDI-DI
    17290110120525
    PMA / PMN Number
    K072564
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. ON LATEST DEVICE RETRIEVAL ATTEMPT, THE FACILITY STATED THAT THEY DID NOT HAVE ANY OTHER INCIDENTS WITH THIS DEVICE. ALMA LTD. CLINICAL REACHED OUT TO AN INDEPENDENT MEDICAL EXPERT FOR FORMAL MEDICAL ASSESSMENT. AS PER THEIR ASSESSMENT, THE PATIENT MAY HAVE HAD AN ALLERGIC REACTION TO ONE OF THE TATTOO COMPONENT. ALMA LTD. CLINICAL REVIEWED THE INFORMATION AND DETERMINED THAT ALTHOUGH PARAMETERS ARE WITHIN RANGE, THE PULSE RATE WITH ENERGY SETTINGS MAY HAVE CAUSED THE OVERLAPPING. THIS MAY HAVE RESULTED IN EXCESSIVE HEAT LEADING TO THE UNTOWARD SKIN REACTION. AS PER THE RECENT FOLLOW-UP, THE FACILITY HAS NOT NOTICED ANY EVIDENCE OF HYPER OR HYPO PIGMENTATION, AND THE PATIENT IS HEALING. ALMA LTD. CLINICAL HAS REVIEWED THE FOLLOW-UP INFORMATION AND DETERMINED THIS EVENT TO BE REPORTABLE DUE TO PATIENT'S CLAIM OF VISITING THE ER, AND IS SUBMITTING THIS REPORT TO THE FDA IN GOOD FAITH EFFORTS. SHOULD ANY INFORMATION BECOME AVAILABLE, ALMA WILL SUBMIT SUPPLEMENTAL REPORT(S) WITHIN THE FDA PUBLISHED TIMELINES.

    Description of Event or Problem · 0

    THE SUSPECTED DEVICE WAS USED ON THE PATIENT'S RIGHT LEG (ANKLE TO CALF) FOR TATTOO REMOVAL. THE FACILITY REPORTED SEVERE PAIN, BLISTERING AND SWELLING. AS PER THE FACILITY, THEY ADVISED THE PATIENT NOT TO PICK AT ANY SCABS OR BLISTERS, AND TO KEEP THE AREA CLEAN AND MOISTURIZED. LATER, THE PATIENT ADMITTED TO THE FACILITY THAT HE DRAINED HIS BLISTERS AND WEARS STEEL TOE BOOTS AT WORK. THE PATIENT WAS REQUESTED TO COME IN FOR EVALUATION BY THE FACILITY DOCTOR, HOWEVER, HE WENT TO THE ER. ACCORDING TO THE FACILITY, THE MEDICATION BEING USED IS IBUPROFEN. THE FACILITY STATED THEY FOLLOWED UP WITH THE PATIENT BUT HE HAS REFUSED TO COOPERATE AND DOES NOT FOLLOW INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155659 HARMONY XL MEDICAL LASER GEX ALMA LASERS LTD Q SWITCH 17290110120525

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other