BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THOR PHOTOMEDICINE LTD

    MDR report key: 18918778 · Received March 15, 2024

    Report

    Report Number
    3003899624-2024-00001
    Event Type
    Malfunction
    Date Received
    March 15, 2024
    Date of Event
    February 19, 2024
    Report Date
    March 15, 2024
    Manufacturer
    THOR PHOTOMEDICINE LTD
    Product Code
    ILY
    PMA / PMN Number
    K033923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING OF THE 1W LASER CLUSTER PROBE DID NOT FIND ANY FAULTS WITH THE PROBE. THOR HAS DONE A PROBE TEMPERATURE TEST, RUNNING THE PROBE FOR 10 MINUTES. AT 0 SEC, THE PROBE TEMPERATURE MEASURED 21.4 DEGREES C, AT 1 MIN IT HAD REACHED 21.4 DEGREES C, AT 10 MINS IT MEASURED 28.2 DEGREES C.

    Description of Event or Problem · 0

    USED ON PATIENT'S POSTERIOR NECK FOR 3 MINUTES ON ONE SIDE OF THE NECK, TOOK A 5 MINUTE BREAK, TREATED OTHER SIDE - THE PROBE GOT VERY HOT AFTER 2 MINUTES. NO BURNS OR POST LASER IRRITATION REPORTED. PRACTITIONER USED IT THAT EVENING ON THEIR ABDOMEN, PROBE GOT HOT AFTER 90 SECONDS. AFTER NOT USING IT FOR A WEEK, PRACTTIONER USED IT OVER THEIR KNEE FOR 3 MINUTES, PROBE DID NOT GET HOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966815 THOR PHOTOMEDICINE LTD 810NM 1W CLUSTER (5X200MW) ISSUE 2 ILY THOR PHOTOMEDICINE LTD S2160

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female