BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENTAL FLOSS

    MDR report key: 4113709 · Received May 1, 2014

    Report

    Report Number
    1825660-2014-00821
    Event Type
    Injury
    Date Received
    May 1, 2014
    Date of Event
    April 2, 2014
    Report Date
    May 1, 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 ADD'L INFO 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

    ON (B)(6) CONSUMER WAS PREPARING TO GO TO AN APPOINTMENT WITH HIS PERIODONTIST WHEN HE BROKE A TOOTH WHILE USING OUR FLOSSER. IT WAS A #11 MEDIAL. HE AND HIS WIFE HAVE FOUND THE VERY SLIM FLOSS CATCHES IN THEIR TEETH AND CAUSES THEM TO HAVE TO USE UNUSUAL FORCE TO GET THE FLOSS OUT. CONSUMER SOUGHT MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262409 DENTAL FLOSS DENTAL FLOSS JES RANIR, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention