BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THOR PHOTOMEDICINE LTD

    MDR report key: 18918775 · Received March 15, 2024

    Report

    Report Number
    3003899624-2024-00002
    Event Type
    Malfunction
    Date Received
    March 15, 2024
    Date of Event
    July 3, 2020
    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
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TEMPERATURE TESTING PERFORMED ON S2160 810 CLUSTER S/N (B)(6) - THIS WAS WITHIN ACCEPTED SPECS. HOWEVER, CABLE REQUIRED REPLACEMENT. 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

    810 CLUSTER PROBE OVERHEATS AFTER 3 MINS, NEEDS TO STAY OFF FOR AT LEAST 3-5 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965847 THOR PHOTOMEDICINE LTD 810NM 1W CLUSTER (5X200MW) ISSUE 1 ILY THOR PHOTOMEDICINE LTD S2160

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown