BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THOR PHOTOMEDICINE LTD

    MDR report key: 18918774 · Received March 15, 2024

    Report

    Report Number
    3003899624-2024-00003
    Event Type
    Malfunction
    Date Received
    March 15, 2024
    Date of Event
    March 22, 2021
    Report Date
    March 15, 2024
    Manufacturer
    THOR PHOTOMEDICINE LTD
    Product Code
    ILY
    UDI-DI
    05060494130145
    PMA / PMN Number
    K033923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PROBE EXCEEDED TEMPERATURE TESTS AFTER 10 MINS (44.5 C). THOR RECOMMENDED THE REPLACEMENT OF THE PROBE HEAD IN ORDER TO RECTIFY THIS, THIS REPAIR WAS REFUSED BY THE CUSTOMER BUT OTHER REPAIR / SERVICING WAS CARRIED OUT. LETTER SENT TO CUSTOMER RE.PROBE TEMPERATURES AND ADVICE REGARDING DUTY CYCLE. THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORT BASED ON ENHANCEMENTS MADE TO THE COMPANY'S COMPLAINT HANDLING PROCESSES. THIS EVENT IS BEING FILED IN ACCORDANCE WITH A CAPA WHICH HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF COMPLAINT FILES AND ANY REQUIRED MDR REPORTING.

    Description of Event or Problem · 0

    810NM 1W CLUSTER PROBE HEATS UP TO THE POINT IT IS UNCOMFORTABLE TO LEAVE IT ON THE SKIN WHEN TREATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965846 THOR PHOTOMEDICINE LTD 810NM 1W CLUSTER (5X200MW) ISSUE 1 ILY THOR PHOTOMEDICINE LTD S1160 05060494130145

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown