BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERIOLASE DENTAL RAZOR

    MDR report key: 13514550 · Received February 10, 2022

    Report

    Report Number
    MW5107402
    Event Type
    Injury
    Date Received
    February 10, 2022
    Date of Event
    August 6, 2021
    Report Date
    February 10, 2022
    Manufacturer
    MILLENNIUM DENTAL TECHNOLOGIES, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    CALLER STATED THAT SHE HAD A LANAP PROCEDURE DONE ON (B)(6) 2021 AFTER WHICH SHE STARTED HAVING PROBLEMS. THE PROCEDURE WAS DONE ON THE BOTTOM RIGHT SIDE OF HER MOUTH. AFTER THE PROCEDURE SHE GOT AN INFECTION AND THE DOCTOR REFUSED TO TREAT THE INFECTION WHICH ALMOST KILLED HER. SHE FURTHER STATED THAT MILLENNIUM DENTAL IS THE INVENTOR AND MANUFACTURER OF THIS DEVICE, SHE CONTACTED THE MANUFACTURER AND THEY REFERRED HER TO THE DENTIST STATING THAT HE HAS GONE THROUGH THE TRAINING AND IS CAPABLE OF PERFORMING THE PROCEDURE. SHE SAID SHE IS STILL GOING THROUGH PAIN. SHE ALSO STATED THAT SHE IS GONE THROUGH FOUR COURSES OF ANTIBIOTICS AND IS CONTINUING TO GO THROUGH TREATMENT TO ALLEVIATE THE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74577 PERIOLASE DENTAL RAZOR POWERED LASER SURGICAL INSTRUMENT GEX MILLENNIUM DENTAL TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention