BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    810NM 1W CLUSTER (5X200MW) ISSUE 1

    MDR report key: 18279422 · Received December 6, 2023

    Report

    Report Number
    3003899624-2023-00004
    Event Type
    Malfunction
    Date Received
    December 6, 2023
    Date of Event
    June 5, 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

    FAULTS CONFIRMED. BLUE WIRE SHORTED TO GROUND IN 1.5M CABLE. REPLACED COMPLETE CABLE. NO CORRECTIVE ACTION WAS REQUIRED. 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

    ON THE LAST USE, THE MIDDLE SECTION OF THE 810NM 1W CLUSTER (5X200MW) ISSUE 1 WAS HOT TO TOUCH - NOT THE HEAD BUT THE MID SECTION OF THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876342 810NM 1W CLUSTER (5X200MW) ISSUE 1 ILY THOR PHOTOMEDICINE LTD S2160

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown