BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENTAL TAPE

    MDR report key: 4890230 · Received July 4, 2015

    Report

    Report Number
    1825660-2015-00070
    Event Type
    Injury
    Date Received
    July 4, 2015
    Date of Event
    June 2, 2015
    Report Date
    July 1, 2015
    Manufacturer
    RANIR LLC
    Product Code
    JES
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DEVICE UNATTENDED

    Narratives

    Additional Manufacturer Narrative · 1

    FLOSS TENSILE STRENGTH IS LESS THAN THE FORCE REQUIRED TO DAMAGE A HEALTHY TOOTH. TOOTH MAY HAVE HAD SOME PREDISPOSITION TO BREAKAGE.

    Description of Event or Problem · 1

    CONSUMER REPORTED THE FLOSS BROKE HIS TOOTH.

    Description of Event or Problem · 1

    CONSUMER REPORTED THE FLOSS BROKE HIS TOOTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434201 DENTAL TAPE DENTAL FLOSS JES RANIR LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability