BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONY XL

    MDR report key: 7585048 · Received June 8, 2018

    Report

    Report Number
    3004167969-2018-00004
    Event Type
    Injury
    Date Received
    June 8, 2018
    Date of Event
    March 26, 2018
    Report Date
    May 11, 2018
    Manufacturer
    ALMA LASERS LTD
    Product Code
    GEX
    UDI-DI
    17290110120327
    PMA / PMN Number
    K072564
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION LETTER (E2013012) ALMA LTD. (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF ALMA INC. (IMPORTER). (SECTION H.3) ALMA LASERS INC. (IMPORTER) SENT SHIPPING LABEL TO THE FACILITY AND REQUESTED THE DEVICE RETURN. ALMA LASERS FOLLOWED UP WITH THE FACILITY AND REMINDED THEM TO SEND BACK THE DEVICE. AS OF TODAY, FACILITY HAS NOT USED THE SHIPPING LABEL. ALMA LASERS INVESTIGATED THE REPORTED ISSUE AND REQUESTED THE FACILITY FOR ADDITIONAL INFORMATION TO ASSIST IN APPROPRIATELY INVESTIGATING THE ALLEGED ADVERSE EVENT. ALMA LASERS REPEATEDLY REQUESTED THE FACILITY TO PROVIDE PRE AND POST TREATMENT PATIENT PHOTOGRAPHS AND THE PATIENT OUTCOME TO ASSESS THE EXTENT OF PATIENT INJURY FOR REPORTABILITY EVALUATION. ACCOUNT INFORMED ALMA LASERS INC. THAT THEIR LEGAL COUNSEL HAS ADVISED THEM AGAINST SHARING ANY INFORMATION. ALMA LASERS WILL CONTINUE TO MAKE ATTEMPTS TO SEEK ADDITIONAL INFORMATION AND RETRIEVE DEVICE FOR INSPECTION. BASED ON THE INFORMATION PROVIDED BY THE FACILITY, ALMA LASERS LTD CHIEF SCIENTIST OFFICER DETERMINED THAT ALTHOUGH THE TREATMENT PARAMETERS ARE WITHIN THE ACCEPTABLE RANGE, GIVEN PATIENT'S DARKER SKIN TYPE, A SKIN TEST SHOULD HAVE BEEN CONDUCTED WHICH MAY HAVE PREVENTED THE PATIENT UNTOWARD SKIN REACTION. IN THE ABSENCE OF VISUAL EVIDENCE, ALMA LASERS CANNOT CROSS-VALIDATE THE ALLEGED DIAGNOSIS GIVEN BY THE PATIENT DERMATOLOGIST. HOWEVER, ALMA LASERS IS SUBMITTING THIS REPORT TO THE FDA IN GOOD FAITH EFFORTS AND AFOREMENTIONED ALMA WILL CONTINUE TO GATHER MORE INFORMTAION. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE; ALMA LASERS LTD WILL FILE A FOLLOW-UP REPORT WITHIN THE TIME LINES PUBLISHED BY THE FDA.

    Description of Event or Problem · 0

    THE SUSPECTED DEVICE WAS USED ON THE PATIENT WITH SKIN TYPE III-IV ON THE ABDOMEN, UPPER PORTION OF BACK AND LOWER BREAST AREA FOR LESIONS. AS PER THE FACILITY NOTES, PATIENT CALLED THEM ON (B)(6) 2018 ABOUT DEVELOPING REDNESS IN SOME OF THE TREATED AREAS. FACILITY TOLD THE PATIENT TO COME IN FOR EVALUATION AND RECOMMENDED BACITRACIN OINTMENT. UPON FOLLOW-UP, PATIENT REPORTED THAT SHE HAS DEVELOPED BLISTERS. FACILITY DIRECTED THE PATIENT TO VISIT THEM FOR EVALUATION. BLISTERS WERE NOTED ON ABDOMINAL AND CHEST AREA, HOWEVER, NO BLISTERS WERE OBSERVED ON THE BACK. IT WAS RECOMMENDED TO THE PATIENT TO SEE A DERMATOLOGIST. AS PER THE FACILITY, PATIENT TOLD A STAFF MEMBER THAT SHE DID NOT APPLY BACITRACIN OINTMENT AS SUGGESTED THE DAY BEFORE. IT WAS REPORTED THAT THE PATIENT WAS USING MEDICATIONS VYTORIN AND SYNTHROID. HER HEALTH AT THE TIME OF TREATMENT AND COMPLAINT WAS DESCRIBED AS GOOD. PATIENT THEN WENT TO SEE THE DERMATOLOGIST WHO GAVE THE DIAGNOSIS OF SECOND DEGREE BURNS AND PRESCRIBED 10 G STRATADERM. FACILITY REPORTED THE ALLEGED ADVERSE EVENT TO ALMA LASERS ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424086 HARMONY XL MEDICAL LASER GEX ALMA LASERS LTD DYE VL 17290110120327

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other