BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THOR PHOTOMEDICINE LTD

    MDR report key: 20890997 · Received December 10, 2024

    Report

    Report Number
    3003899624-2024-00007
    Event Type
    Malfunction
    Date Received
    December 10, 2024
    Date of Event
    November 11, 2024
    Report Date
    December 10, 2024
    Manufacturer
    THOR PHOTOMEDICINE LTD
    Product Code
    ILY
    UDI-DI
    05060494130558
    PMA / PMN Number
    K033923
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRACTITIONER REPORTED THAT THE PATIENT HAD PREVIOUSLY ATTENDED TEN APPOINTMENTS FOR THE SAME TREATMENT, USING THE SAME LASER PROBE, WITH IDENTICAL SETTINGS, DURATION, AND APPLICATION TO SOME OF THE SAME BODY AREAS, WITHOUT ANY ADVERSE EFFECTS. SINCE THE PATIENT REPORTED THIS EVENT, THE PRACTITIONER NOTED THAT THE PATIENT REMAINED FINE AND UNCONCERNED. THEY ALSO NOTED THAT THE SAME PROBE HAD BEEN USED SUBSEQUENTLY ON SEVERAL OTHER PATIENTS, STAFF MEMBERS, AND EVEN THEMSELVES WITHOUT ANY REPORTS OF HEATING, BURNING, OR OTHER ADVERSE EFFECTS. SINCE 2021, OVER 100 OF THESE PROBES HAVE BEEN IN REGULAR USE, TYPICALLY MULTIPLE TIMES PER DAY, RESULTING IN THOUSANDS OF PATIENT TREATMENTS WITHOUT ANY REPORTED ADVERSE EVENTS. ADDITIONALLY, EXPERIMENTAL USE OF THE PROBE FOR UP TO SIX MINUTES ON A SINGLE ANATOMICAL LOCATION REVEALED NO SIGNIFICANT HEATING OR ADVERSE EFFECTS. INVESTIGATIONS ARE ONGOING TO DETERMINE WHETHER OTHER FACTORS CONTRIBUTED TO OR CAUSED THIS INCIDENT. THE PROBE HAS BEEN REQUESTED TO BE RETURNED FOR TESTING.

    Description of Event or Problem · 0

    PRACTITIONER USED THE GLC ON A PATIENT WHO HAS HAD THIS SAME TREATMENT MANY TIMES. AFTER THEY GOT HOME, THEY REPORTED WHAT THEY THOUGHT LOOKED LIKE A BURN MARK ON THE SKIN, THE PATIENT DID NOT REPORT ANY DISCOMFORT OR SENSATION AT THE TIME OF TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1504870 THOR PHOTOMEDICINE LTD 810NM 16W LASER CLUSTER (80X200MW) ISSUE 2, PRODUCT CODE: ILY ILY THOR PHOTOMEDICINE LTD S2195 05060494130558

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female