BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPHI

    MDR report key: 6998574 · Received November 3, 2017

    Report

    Report Number
    3004724437-2017-00002
    Event Type
    Injury
    Date Received
    November 3, 2017
    Date of Event
    June 7, 2017
    Report Date
    November 30, 2017
    Manufacturer
    ASA SRL
    Product Code
    ILY
    PMA / PMN Number
    K111901
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    SERVICE PERSONNEL

    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 BEEN EXPERIENCING A TEMPORARY SKIN RASH MONTHS BEFORE THE COMPLAINT SUBMISSION AND NOW HE DOESN'T HAVE REPORTED ANY CONSEQUENCES. THEREFORE, THE FOLLOWING DEFINITION IS NOT APPLICABLE TO THIS CASE: (W) 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. THE SERVICE ACTIVITIES PERFORMED ON THE DEVICE AFTER ITS SALE DIDN'T SHOW PROBLEMS RELATED TO THE EMISSION VALUES OF THE DEVICE. THE LASER EMISSION MEASUREMENTS TAKEN AFTER THE EVENT DON'T SHOW ANY OVER-EMISSION 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. MOREOVER, THE SCIENTIFIC LITERATURE DOESN'T SHOW ANY CONTRAINDICATIONS IN USING DIODE LASER EMISSIONS WITH TITANIUM PLAQUES. 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 BACK PAIN AND SKIN RASH ON THE BACK OF THE NECK AFTER THE 3TH SESSION OF THE THERAPY

    Description of Event or Problem · 1

    THE PATIENT REPORTED BACK PAIN AND SKIN RASH ON THE BACK OF THE NECK AFTER THE 3TH SESSION OF THE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780390 MPHI LASER THERAPY ILY ASA SRL F9000221

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other