BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPHI

    MDR report key: 6979702 · Received October 26, 2017

    Report

    Report Number
    3004724437-2017-00001
    Event Type
    Injury
    Date Received
    October 26, 2017
    Date of Event
    September 15, 2017
    Report Date
    November 24, 2017
    Manufacturer
    ASA SRL
    Product Code
    ILY
    PMA / PMN Number
    K111901
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADEQUATE INFORMATION TO COMPLETE THE INVESTIGATION ON THE CASE IS NOT YET AVAILABLE. THE INVESTIGATION ACTIVITIES CONTINUE AND WILL FOLLOW FOLLOW-UP.

    Additional Manufacturer Narrative · 1

    AFTER ANALYZING THE DOCUMENTATION, WE BELIEVE THAT THE REPORTED EVENT CANNOT BE CONSIDERED A SERIOUS INJURY. THE PATIENT HAS A TRIVIAL (SUPERFICIAL AND TEMPORARY) SKIN DAMAGE. THEREFORE, THE FOLLOWING DEFINITION IS NOT APPLICABLE TO THIS CASE: SERIOUS INJURY MEANS AN INJURY OR ILLNESS THAT: IS LIFE-THREATENING, RESULTS IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, OR NECESSITATES MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. PERMANENT MEANS IRREVERSIBLE IMPAIRMENT OR DAMAGE TO A BODY STRUCTURE OR FUNCTION, EXCLUDING TRIVIAL IMPAIRMENT OR DAMAGE. THE DHR DOESN'T SHOW ANY IRREGULARITIES DURING THE PRODUCTION PHASE AND SHOWS CORRECT AND REGULAR VALUES IN THE LASER EMISSION, FUNCTIONAL AND ELECTRICAL SAFETY TESTS. NO SERVICE ACTIVITIES HAVE BEEN PERFORMED ON THE DEVICE AFTER THE SALE OF THE DEVICE. THE LASER EMISSION MEASUREMENTS TAKEN AFTER THE EVENT DON'T SHOW ANY ANOMALIES IN THE SYSTEM. THE SCHEDULED POST-MARKET MONITORING OF THE TREATMENTS PERFORMED WITH SAME OR SIMILAR DEVICES DOESN'T SHOW ANY UNDESIRABLE SIDE EFFECTS SIMILAR TO THE ONES DESCRIBED IN THIS CASE, NEITHER WITH THE SAME TREATING PARAMETERS, NOR WITH DIFFERENT TREATING PARAMETERS. ACCORDING TO OUR ANALYSIS, THERE ARE NO ACTIONS TO BE TAKEN ON THE DEVICE OR ON THE MARKET. HOWEVER, WE WILL MAINTAIN A HIGH LEVEL OF MARKET SURVEILLANCE TO MONITOR SIMILAR EVENTS. IF THE FDA DOESN'T HAVE ANY FURTHER NOTES REGARDING THIS CASE, WE CONSIDER THE CASE CLOSED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED A RED BURN, ITCHY LESION ON RIGHT POSTERIOR SHOULDER A FEW HOURS AFTER THE FIRST THERAPY SESSION.

    Description of Event or Problem · 1

    THE PATIENT REPORTED A RED BURN, ITCHY LESION ON RIGHT POSTERIOR SHOULDER A FEW HOURS AFTER THE FIRST THERAPY SESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759840 MPHI LASER THERAPY ILY ASA SRL F9000235

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other IBUPROFEN