BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BODOR LASER

    MDR report key: 21449442 · Received February 24, 2025

    Report

    Report Number
    MW5166759
    Event Type
    Injury
    Date Received
    February 24, 2025
    Date of Event
    December 1, 2024
    Report Date
    February 21, 2025
    Manufacturer
    BEIJING UNT TECHNOLOGY CO., LTD.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    CALL RECEIVED IN REFERENCE TO A BODOR LASER DEVICE THAT HAS HAD A RECALL NOTICE BY THE FDA. REPORTER STATED THAT HE RECENTLY PURCHASED THE BODOR LASER DEVICE AND SHORTLY AFTERWARDS, LEARNED OF A RECALL ON THESE DEVICES DUE TO NON-COMPLIANT SAFETY FEATURES. HIS MACHINE WAS SHIPPED WITH ALL THE NECESSARY SAFETY PARTS AND THE MANUFACTURER PROVIDED PERSONNEL TO ASSEMBLE THE DEVICE. THE DEVICE HAS ONLY BEEN PARTIALLY ASSEMBLED AS OF TODAY SINCE DECEMBER 2024 WHEN FIRST RECEIVED FROM OVERSEAS. THE MANUFACTURER HAS BEEN TELLING THE REPORTER THAT HE HAS TO GET FDA APPROVAL FOR FURTHER ASSEMBLY OF THE DEVICE AND THEN CONFIRMATION FOR IT'S SAFE USE WHICH IS INCONSISTENT WITH A LETTER THAT HE RECEIVED FROM THE MANUFACTURER OF THE BODOR LASER DEVICE. REPORTER IS SEEKING MORE INFORMATION ABOUT HOW TO GET THE MANUFACTURER TO FINISH ASSEMBLING THIS DEVICE AND THEN APPROVAL FOR ITS SAFE USE. THIS DEVICE COST APPROXIMATELY ONE-HALF MILLION DOLLARS AND THE REPORTER HOPES TO NOT HAVE TO TAKE A LOSS OVER A FAULTY OR INOPERATIVE PIECE OF EQUIPMENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 12 MARCH 2025 FOR MW5166759: MFR UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BODOR LASER POWERED LASER SURGICAL INSTRUMENT GEX BEIJING UNT TECHNOLOGY CO., LTD. P6

    Patients

    Seq Age Sex Outcome Treatment
    1