BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONY

    MDR report key: 5844017 · Received August 3, 2016

    Report

    Report Number
    3004167969-2013-00002
    Event Type
    Injury
    Date Received
    August 3, 2016
    Date of Event
    August 28, 2013
    Report Date
    August 28, 2013
    Manufacturer
    ALMA LASERS LTD
    Product Code
    GEX
    PMA / PMN Number
    K072564
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THIS IS A RESUBMISSION OF A PREVIOUSLY SUBMITTED MDR IN 2013. PLEASE SEE SUBMISSION COMMENT FOR EXPLANATION. REASONABLE ATTEMPTS WERE MADE VIA PHONE CALL(S) AND E-MAIL(S) TO OBTAIN ADDITIONAL INFORMATION FOR COMPLETION OF THE REPORT AND FOLLOW-UP ON PATIENT'S MEDICAL CONDITION. THE SPA DID NOT COOPERATE AND REFUSED TO PROVIDE ANY INFORMATION IN SPITE OF ALMA'S GOOD FAITH EFFORT. CONSEQUENTLY ALMA INC AND LTD WERE UNABLE TO DETERMINE PATIENT'S CONDITION AND ANY OTHER ADDITIONAL INFORMATION NEEDED FOR COMPLETION OF THE REPORT. SHOULD ANY ADDITIONAL INFORMATION BE PROVIDED BY THE SPA, ALMA LTD WILL FILE FOLLOW-UP REPORT(S) WITH FDA. AN INITIAL EXAMINATION OF THE SUBJECT DEVICE WAS PERFORMED AT ALMA INC. CONCLUDING THAT THE CAP CHARGER OF THE SUBJECT DEVICE WAS DAMAGED. THE DEVICE MET SPECIFICATIONS WITH A REPLACEMENT CAP CHARGER. THE DEVICE IS QUARANTINED FOR FURTHER INVESTIGATION. THE ROOT CAUSE OF THE EVENT IS UNKNOWN AT THIS TIME. THE CAP CHARGER IS BEING FORWARDED TO THE SUPPLIER FOR FURTHER ANALYSIS. BASED ON SUPPLIER RESULTS ALMA LTD WILL TAKE NECESSARY ACTIONS AS NEEDED INCLUDING BUT NOT LIMITED TO SUPPLIER REEVALUATION AND/OR ANY OTHER CORRECTIVE AND/OR PREVENTIVE ACTION(S). ALMA LTD WILL FILE FOLLOW-UP REPORT(S) FOR ANY ADDITIONAL INFORMATION AND/OR CORRECTED DATA. WE DO NOT HAVE ADEQUATE INFORMATION ON HER OCCUPATIONAL ROLE TO PROVIDE CORRECT INFORMATION IN OCCUPATION. IT SEEMS SHE WAS THE "SPA DIRECTOR" AND THEN WAS DESIGNATED AS "LEAD LASER TECH". AS MENTIONED EARLIER IN THE REPORT, THE SPA DID NOT COOPERATE IN PROVIDING ANY ADDITIONAL INFORMATION. SHOULD ANY ADDITIONAL INFORMATION BE PROVIDED/OBTAINED BY THE SPA, ALMA LTD WILL FILE FOLLOW-UP REPORTS) WITH FDA.

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THIS IS A RESUBMISSION OF A PREVIOUSLY SUBMITTED MDR FOLLOW UP IN 2013. PLEASE SEE SUBMISSION COMMENT FOR EXPLANATION. EXEMPTION NUMBER E2013012. ALMA LTD RECEIVED INVESTIGATION RESULTS FROM SUPPLIER OF THE FAILED COMPONENT AND THEREFORE ALMA LTD. IS SUBMITTING THIS FOLLOW-UP REPORT # 1. PLEASE SEE ATTACHMENT FOR SUPPLIER ANALYSIS ON THE FAILED COMPONENT AND ACTIONS TAKEN. DATE RECEIVED BY MFR IS UPDATED BASED ON THE DATE WHEN FOLLOW UP INFORMATION WAS RECEIVED FROM SUPPLIER. TYPE OF REPORTS IS UPDATED FOR TYPE OF REPORT AND FOLLOW UP NUMBER. IF FOLLOW-UP, WHAT TYPE? IS UPDATED FOR TYPE OF FOLLOWUP. EVALUATION CODES IS UPDATED FOR RESULTS AND CONCLUSION CODES BASED ON SUPPLIER INVESTIGATION RESULTS.

    Description of Event or Problem · 0

    OPERATOR OF THE SUBJECT DEVICE REPORTED THAT SHE WAS IN THE MIDDLE OF A PROCEDURE WHEN SHE HEARD A HUGE BOOM. SHE HAD HER BACK TO THE SYSTEM. SHE QUICKLY REALIZED THAT IT WAS THE SUBJECT DEVICE AND UNPLUGGED IT. THE PATIENT WAS FINE BUT THE OPERATOR HERSELF EXPERIENCED EAR PAIN AND THOUGHT HER EARS WERE BLEEDING. OPERATOR DID MAKE A REMARK THAT AT THE TIME OF PROCEDURE THERE WERE TWO SYSTEMS (DEVICES) PLUGGED INTO THE SAME ELECTRICAL OUTLET AS SHE INTENDED TO FOLLOW-UP THE Q SWITCH TREATMENT WITH NIR TREATMENT ON THE PATIENT'S FACE. OPERATOR (HEREAFTER, DESIGNATED AS PATIENT FOR THIS EVENT) WENT TO EMERGENCY ROOM AND WAS REFERRED TO AN ENT SPECIALIST. PRELIMINARY DIAGNOSIS WAS MILD HEARING LOSS WHICH COULD BE TEMPORARY. THE PAIN SHOULD SUBSIDE IN 8 DAYS OTHERWISE SHE WAS ADVISED TO RETURN FOR A FOLLOWUP. SHE WAS PRESCRIBED MOTRIN FOR HER SYMPTOMS OF PAIN IN EARS AND HEADACHE IN THE BACK OF HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495631 HARMONY MEDICAL LASER GEX ALMA LASERS LTD XL

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other