BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOSSER

    MDR report key: 4241395 · Received November 10, 2014

    Report

    Report Number
    1825660-2014-00950
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    September 26, 2014
    Report Date
    November 10, 2014
    Manufacturer
    RANIR, LLC
    Product Code
    JES
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    "...WAS POKING THEM ALONG MY GUMS. A COUPLE OF THE TEETH BROKE OFF INTO MY GUM. HAD TO GO TO PERIODONTIST TO HAVE IT REMOVED. THE TEETH THINGS IRRITATE THE GUMS". (AT THE INITIAL REPORT BY CONSUMER, IT SOUNDED AS IF HIS TEETH BROKE OFF IN THE GUM - HENCE, NEEDING TO SEE A PERIODONTIST.) AFTER THE DEVICE AND MEDICAL RECORDS WERE REQUESTED AND FURTHER DISCUSSION WITH CONSUMER ON (B)(6) 2014, IT WAS DETERMINED THAT THE FLOSSER WAS MISIDENTIFIED BY THE CONSUMER AND THIS IS A TOOTHPICK WITH TINY "TEETH" ON THE END. THE TINY TEETH BROKE WHEN THE CONSUMER PRESSED IT INTO HIS GUMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721697 FLOSSER FLOSSING DEVICE WITH TOOTHPICK END JES RANIR, LLC FLOSSER

    Patients

    Seq Age Sex Outcome Treatment
    1