BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENTAL FLOSSERS

    MDR report key: 3912924 · Received June 10, 2014

    Report

    Report Number
    1825660-2014-00852
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 20, 2014
    Report Date
    June 5, 2014
    Manufacturer
    RANIR, LLC.
    Product Code
    JES
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS GIVEN BY THE CONSUMER. NO LOT CODE WAS GIVEN, NO PRODUCT WAS RETURNED FOR INVESTIGATION. TOOTH FRACTURE IS CONSIDERED A SERIOUS INJURY AND A REPORTABLE EVENT. HOWEVER, DENTAL PROFESSIONALS HAVE INDICATED THAT A HEALTHY TOOTH CANNOT BE BROKEN, FRACTURED, OR OTHERWISE COMPROMISED, AND FOR THIS TYPE OF INJURY TO OCCUR THE CONSUMER'S TEETH HAD TO BE COMPROMISED IN SOME FASHION AND IS NOT A RESULT OF THE FLOSS ITSELF.

    Description of Event or Problem · 1

    HER TEETH ARE TIGHT AND AFTER TRYING IT SHE ENDED UP GETTING THE FLOSS STUCK BETWEEN HER TEETH AND BROKE HER TEETH. HAD TO GET CROWN WORK WHICH COST (B)(6). TRIED IT AGAIN AND THANKFULLY IT DIDN'T CAUSE ANY DAMAGE BUT IT GOT STUCK BETWEEN HER TEETH AGAIN AND SHE HAD TO TAKE SCISSORS AND CUT THE FLOSS OUT, CAREFULLY SINCE IT WAS IN THERE SO SECURE. FLOSS HURT HER GUM TISSUE WHICH WAS NO BIG DEAL. SINCE SHE HAD TO PULL THE FLOSS AGAIN BECAUSE SHE COULDN'T CUT IT WHERE IT WAS AT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338521 DENTAL FLOSSERS DENTAL FLOSSERS JES RANIR, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention