BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRA LUX MULTFLEX 635B OR RONDOFLEX

    MDR report key: 962525 · Received December 12, 2007

    Report

    Report Number
    1419798-2007-00025
    Event Type
    Injury
    Date Received
    December 12, 2007
    Date of Event
    November 9, 2007
    Report Date
    November 12, 2007
    Manufacturer
    KAVO DENTAL
    Product Code
    KOJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DOCTOR REFUSED TO SEND IN EITHER ITEM TO KAVO FOR REPAIR. DOCTOR SAID NOTHING WAS WRONG WITH THE EQUIPMENT. DOCTOR PUT PIECES BACK INTO ROTATION, SO THE EXACT DEVICE USED CANNOT BE IDENTIFIED FOR EVALUATION.

    Description of Event or Problem · 1

    AN AIR EMBOLISM WAS CAUSED TO PATIENT'S EYE DURING PROCEDURE. WHILE DOCTOR WAS WORKING ON TOOTH 21, HE NOTICED A PERCOLATION OF THE TISSUE. PATIENT'S EYE BECAME RED AND PUFFY. DOCTOR SAID THIS WAS NOT AN ALLERGIC REACTION. PATIENT WAS PRESCRIBED CLINDAMYCIN. PATIENT IS HEALING. DOCTOR IS NOT SURE IF IT WAS CAUSED BY HIS 635B OR HIS RONDOFLEX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIRA LUX MULTFLEX 635B OR RONDOFLEX TURBINE OR AIR-ABRASION SYSTEM W/SPRAY KOJ KAVO DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention