BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    660 NM 75 MW DENTAL PROBE

    MDR report key: 20794891 · Received November 27, 2024

    Report

    Report Number
    3003899624-2024-00006
    Event Type
    Malfunction
    Date Received
    November 27, 2024
    Date of Event
    September 16, 2024
    Report Date
    November 27, 2024
    Manufacturer
    THOR PHOTOMEDICINE LTD
    Product Code
    ILY
    UDI-DI
    05060494130114
    PMA / PMN Number
    K033923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE NO REPORTS OF PATIENT OR USER HARM. THE INITIAL USER REPORT DID NOT NOTE ANY CONCERNS, INJURY OR USER HARM. THIS MDR IS BEING SUBMITTED AS A LATER VERBAL REPORT NOTED THE "LIGHT GUIDE BROKE OFF INTO THE HAND OF A NURSE WHO WAS TRYING TO UN-JAM IT"; NO USER HARM OCCURRED, THE USER DID NOT MENTION ANY CONCERN OF POSSIBLE HARM AT ANY POINT. THOR UNDERSTANDS THAT THE SUBMISSION OF THIS MDR REPORT IS DELAYED BEYOND THE 30 DAY PERIOD. THE THIRD PARTY COMPANY THAT WAS AUTHORISED TO SUBMIT THE MDR REPORTS ON BEHALF OF THOR BECAME UNAVAILABLE AND ARE NO LONGER USED. SETTING UP THOR PROFILE ON THE ESG PORTAL WAS A PROTRACTED PROCESS.

    Description of Event or Problem · 0

    NO ADVERSE EVENT OR USER HARM REPORTED. THIS MDR IS BEING SUBMITTED AS A VERBAL REPORT ON 16 SEPT 2024 NOTED THE "LIGHT GUIDE BROKE OFF INTO THE HAND OF A NURSE WHO WAS TRYING TO UN-JAM IT"; NO USER HARM OCCURRED, THE USER DID NOT MENTION ANY CONCERN OF POSSIBLE HARM AT ANY POINT. THIS VERBAL REPORT RELATES TO AN EARLIER REPAIR REQUEST ON JUNE 23 2024 STATING "THE USERS GOT ROUGH WITH HANDPIECE WHILE REMOVING THE BLACK PLASTIC TIP. THE TIP LENSES WERE BROKEN AND NOW A NEW TIP WILL NOT INSERT IN THE HANDPIECE. THEY MUST HAVE BENT THE INTERNAL AREA THAT THE TIP FITS INTO".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844564 660 NM 75 MW DENTAL PROBE ILY THOR PHOTOMEDICINE LTD S2173 05060494130114

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown