BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLACKERS PKFL TWN LN MNT

    MDR report key: 8713742 · Received June 19, 2019

    Report

    Report Number
    1825660-2019-00573
    Event Type
    Malfunction
    Date Received
    June 19, 2019
    Date of Event
    May 22, 2019
    Report Date
    June 19, 2019
    Manufacturer
    RANIR LLC
    Product Code
    JES
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CONSUMER STATED SHE "USED THE DENTAL FLOSS IN CENTER OF MY 2 FRONT TEETH AND IT TOOK A GOOD CHUNK OUT OF ONE OF THEM (LEFT FRONT INCISOR ON UPPER TEETH) IN THE BACK OF TOOTH ALMOST UP TO THE GUM. I USED IT RIGHT. SHE HOPES IT DOESN'T START ACHING AND HAD A DENTAL VISIT SCHEDULED JUNE 13TH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504656 PLACKERS PKFL TWN LN MNT FLOSS, DENTAL JES RANIR LLC PKFL TWN LN MNT 75 8008A

    Patients

    Seq Age Sex Outcome Treatment
    1