BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENTAL FLOSS

    MDR report key: 3970969 · Received June 30, 2014

    Report

    Report Number
    1825660-2014-00872
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 27, 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

    TOOTH FRACTURE AND FILLING/CROWN LOSS ARE WELL-DOCUMENTED ISSUES WHEN USING DENTAL FLOSS. A PROPER DENTAL RESTORATION WILL NOT COME OUT WHEN USING FLOSSER. THE LOSS OF A FILLING CAN OCCUR WHEN A DENTAL RESTORATION THAT IS UNSOUND OR AT THE END OF ITS LIFE IS SUBJECTED TO THE FORCES OCCURRING DURING NORMAL DENTAL HYGIENE. TEETH THAT HAVE IMPROPER OR END-OF-LIFE DENTAL RESTORATIONS CAN HAVE SHARP EDGES WHICH WOULD CUT AND SHRED DENTAL FLOSS. THE USE OF DENTAL FLOSS WITH AN IMPROPERLY RESTORED TOOTH COULD EXACERBATE A PRE-EXISTING CONDITION AND CAUSE UNFORESEEN DAMAGE. THE DENTAL FLOSS WAS NOT RETURNED TO THE MANUFACTURER, NO LOT NUMBER WAS GIVEN, SO WE COULD NOT PERFORM A FULL INVESTIGATION. AT THIS POINT, BEFORE THE INVESTIGATION IS COMPLETED, THERE IS NO INDICATION THAT THE FLOSSER HAS MALFUNCTIONED. THIS IS BEING REPORTED BECAUSE THE CONSUMER HAD TOOTH BREAKAGE WHICH IS CONSIDERED A REPORTABLE EVENT.

    Description of Event or Problem · 1

    CONSUMER CLAIMED THAT WHILE USING THE FLOSSER IT GOT STUCK BETWEEN HIS TEETH. WHEN HE PULLED IT OUT, PART OF HIS TOOTH BROKE. HIS DENTIST SAYS HE MAY NOW NEED A CAP. HE WOULD LIKE US TO PAY HIS DENTAL BILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379267 DENTAL FLOSS DENTAL FLOSS JES RANIR, LLC PLACKERS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention