BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    104 LED CLUSTER PROBE WAVELENGTH = 660NM & 850NM ISSUE 1

    MDR report key: 18279326 · Received December 6, 2023

    Report

    Report Number
    3003899624-2023-00003
    Event Type
    Malfunction
    Date Received
    December 6, 2023
    Date of Event
    July 24, 2023
    Report Date
    December 6, 2023
    Manufacturer
    THOR PHOTOMEDICINE LTD
    Product Code
    ILY
    PMA / PMN Number
    K033923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER DOES NOT WANT TO RETURN THE PRODUCT FOR INVESTIGATION. 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

    104 LED CLUSTER PROBE WAVELENGTH = 660NM & 850NM ISSUE 1 (SN: (B)(6)) PROBE HAS BEEN GETTING MUCH HOTTER THAN PREVIOUS ONES. THIS HAS BEEN NOTED DESPITE USING THE 5 MIN ON TIME (1X5 MINUTES APPLICATION TIME) AND THEN 20 MINUTES IN COOL DOWN TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197255 104 LED CLUSTER PROBE WAVELENGTH = 660NM & 850NM ISSUE 1 ILY THOR PHOTOMEDICINE LTD S2140

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown