BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M8

    MDR report key: 12238195 · Received July 28, 2021

    Report

    Report Number
    3004724437-2021-00002
    Event Type
    Injury
    Date Received
    July 28, 2021
    Date of Event
    May 14, 2021
    Report Date
    July 28, 2021
    Manufacturer
    ASA SRL
    Product Code
    ILY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT UNDERWENT A TOTAL REPLACEMENT OF THE DEXTER HIP JOINT ON (B)(6) 2021. THE DOCTOR PRESCRIBED 3 COLD LASER TREATMENTS TO PATIENT ON MAY 5, 2021, TO BEING AFTER (B)(6) 2021. LASER TREATMENT PERFORMED ON PATIENT ON (B)(6) 2021. RECEIVED LETTER DATED JUNE 23, 2021, ON JUNE 28, 2021 FROM PATIENT CLAIMING "NEGATIVE REACTION" TO HIS RIGHT LEG CAUSED BY THE LASER TREATMENT FROM (B)(6) 2021. PATIENT HAS NOT RETURNED TO THE CLINICAL FACILITY WERE THE TREATMENT WAS PERFORMED SINCE (B)(6) 2021. THE MEDICAL EXPERTS STATED THAT THE SYMPTOMS DESCRIBED WERE A TYPICAL POST-OPERATIVE RESPONSE CALL ECCHYMOSIS (WHERE DARK SPOTS FORM ON THE SKIN CAUSED BY THE BLOOD THAT HAS SEEPED FROM RUPTURED OR SEVERED, BUT HEALING VESSELS). POST-OPERATIVE ECCHYMOSIS TYPICALLY PRESENTS NEAR THE INCISION SITE AND RADIATES FROM THERE, OFTEN TOWARDS THE PATIENT'S LEGS AS GRAVITY WORKS. IT CAN PRESENT IMMEDIATELY OR SOMETIME LATER WHEN THE PATIENT BECOMES MORE ACTIVE AND THE BLOOD MOVES TO THE SURFACE. THAT IS EXACTLY WHAT THE PATIENT DESCRIBES OCCURRED. WE RULED OUT ANY TOPICAL BURNING BY THE LASER, AS THE PROCEDURE WAS ONLY PERFORMED ON THE PATIENT'S THIGH AND THE DISCOLORATION OCCURRED THEREAFTER. 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 JULY 06, 2021, CONFIRMS THE REGULAR FUNCTIONING OF THE DEVICE, THEREFORE A MALFUNCTION OF THE DEVICE ITSELF IS EXCLUDED. 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, 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: (1) IS LIFE-THREATENING, (2) RESULTS IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, OR (3) 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. 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

    RECEIVED LETTER DATED JUNE 23, 2021 FROM PATIENT CLAIMING "NEGATIVE REACTION" TO HIS RIGHT LEG CAUSED BY THE LASER TREATMENT FROM (B)(6) 2021. THE PATIENT WROTE THAT THEY HAVE A TOTAL RIGHT HIP REPLACEMENT ON (B)(6), HAD A LASER TREATMENT ON THE RIGHT HIP ON (B)(6) AND THE THIGH STARTED ACHING AND BURNING, ON (B)(6) THE LEG WAS SWELLING AND BEGINNING TO DISCOLOR. THE PAIN, HEAT IN THE THIGH, SWELLING AND DISCOLORATION LASTED FOR 10 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1136537 M8 LASER THERAPY ILY ASA SRL F900047

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other ALLOPURINO L 300 MG TABLET| APIXABAN 5 MG (74 TABS) TABLETS IN A DOSE PACK| GLIPIZIDE 10 MG TABLET| LOSARTAN 50 MG TABLET| METOPROLOL SUCC 25 MG-HYDROCHLOROTHIAZIDE 12.5 MG| OMEPRAZOLE 10 MG CAPSULE,DELAYED RELEASE| PREGABALIN 100 MG CAPSULE