BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERDENTAL TOOTHBRUSH

    MDR report key: 4241367 · Received November 10, 2014

    Report

    Report Number
    1825660-2014-00948
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 16, 2014
    Report Date
    November 10, 2014
    Manufacturer
    RANIR, LLC
    Product Code
    EFW
    PMA / PMN Number
    K942690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT HAS NOT BEEN CONFIRMED. DEVICE NOT RETURNED TO MANUFACTURER AS OF TODAY, AND NO LOT NUMBER INFORMATION WAS GIVEN SO AN EVALUATION CANNOT BE PERFORMED AS TO THE ROOT CAUSE OR ACTUAL NATURE OF THE PROBLEM.

    Description of Event or Problem · 1

    I WAS USING THIS ITEM AND THE PLASTIC WAS SO BIG, AND IT STUCK IN MY GUM IN THE BACK AND IT HAD A SHARP END AND IT IS VERY BIG, IT IS SUPPOSED TO BE POINTED BUT THESE ARE A BOX SHAPE AND IT WENT IN TO MY GUM, AND THEN I WAS USING THE FLOSS, AND IT BROKE OFF BETWEEN MY TEETH, AND I HAD TO GO TO THE DENTIST AND GET THE FLOSS OUT. I WENT TO THE DENTIST ON FRIDAY, (B)(6) 2014 AND (B)(6) 2014, AND I AM GOING TO CALL THEM TODAY, TO SEE IF THEY CAN SEE ME TODAY, BECAUSE THERE IS SO MUCH PAIN AROUND MY GUM. THE GUM LINER IS COMING DOWN, AND THE DENTIST LOOKED LIKE SHE WAS IN SHOCK. MY MOUTH NOW HAS A BIG BUBBLE ON THE RIGHT SIDE ABOUT 3 TEETH GOING TO THE BACK OF MY MOUTH, AND IT IS MY TOP TEETH AND MY TOP GUMS IS AFFECTED. THIS HAS BEEN GOING ON FOR 3 WEEKS AND I PURCHASED THEM ABOUT 5 WEEKS AGO. I WILL KEEP THE ITEMS AND WAIT FOR SOMEONE TO CALL ME

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723929 INTERDENTAL TOOTHBRUSH MANUAL TOOTHBRUSH EFW RANIR, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other