BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    810NM 1W CLUSTER (5X200MW) ISSUE 1

    MDR report key: 18280669 · Received December 7, 2023

    Report

    Report Number
    3003899624-2023-00009
    Event Type
    Malfunction
    Date Received
    December 7, 2023
    Date of Event
    May 20, 2021
    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
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    810NM 1W CLUSTER PROBE CABLE WAS FAULTY. CABLE REPLACED FOR LASER CLUSTER PROBE. TESTED AND IT WAS WORKING AS INTENDED. 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

    THE RINGS AROUND THE PROBES GET VERY HOT ESPECIALLY WHEN I DO THE LYMPHOEDEMA TREATMENT USING THE LARGE PROBE AND IT CONCERNS ME THAT IT SHOULD NOT BE GETTING THIS HOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730683 810NM 1W CLUSTER (5X200MW) ISSUE 1 ILY THOR PHOTOMEDICINE LTD S2160

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown