BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M6

    MDR report key: 11461320 · Received March 11, 2021

    Report

    Report Number
    3004724437-2021-00001
    Event Type
    Injury
    Date Received
    March 11, 2021
    Date of Event
    February 5, 2021
    Report Date
    February 24, 2021
    Manufacturer
    ASA SRL
    Product Code
    ILY
    PMA / PMN Number
    K051922
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 1

    THE TREATMENT WAS PERFORMED WITH THE HANDPIECE IN CONTACT WITH THE SKIN WITHOUT THE INTERPOSITION OF CREAMS OR OTHER MEANS. THE PATIENT REFUSED TO BE EXAMINED BY THE DOCTOR FOR THE EVALUATION OF THE INCIDENT AND DESPITE REPEATED REQUESTS, WE ARE NOT ABLE TO HAVE INFORMATION ON PREVIOUS DISEASES OF THE PATIENT AND ANY MEDICATIONS TAKEN, SO IT IS NOT POSSIBLE TO MAKE A CLINICAL EVALUATION OF THE INCIDENT. THE DHR CHECK OF THE DEVICE AND THE HISTORY OF ITS SERVICE INTERVENTIONS DO NOT SHOW ANY ANOMALIES THAT COULD BE RELATED TO ANOMALOUS LASER EMISSIONS. THE TECHNICAL CHECK CARRIED OUT ON MARCH 02, 2021, CONFIRMS THE REGULAR FUNCTIONING OF THE DEVICE, THEREFORE A MALFUNCTION OF THE DEVICE ITSELF IS EXCLUDED. DESPITE REPEATED REMINDERS OF 24 FEB, 4 MARCH, AND 5 MARCH WE HAVE NOT RECEIVED ANY FURTHER INFORMATION FOR THE EVALUATION OF THE PATIENT'S HEALTH STATUS, SO BASED ON THE ANALYSIS OF THE GATHERED DATA WE BELIEVE THAT THERE ARE NO FURTHER ACTIVITIES TO BE PERFORMED 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 DOCTOR REPORTED THAT THE PATIENT CLAIMS A BURN ON HER RIGHT KNEE AND RIGHT HIP. THREE DAYS AFTER THE TREATMENT, THE PATIENT CLAIMED A BURN AND SAID THE LASER CAUSED THE BURN ON HER RIGHT KNEE, NON-MENTION OF THE HIP. THE PATIENT DID STATE THAT SAW TELEDOC AND THEY GAVE HER A CREAM FOR THE SAID BURN. THE PATIENT REFUSES TO SEE THE DOCTOR TO EVALUATE THE CLAIMED BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359360 M6 LASER THERAPY ILY ASA SRL F9000207

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other