BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCED CARE FLOSSERS

    MDR report key: 15179504 · Received August 5, 2022

    Report

    Report Number
    0001413787-2022-00283
    Event Type
    Injury
    Date Received
    August 5, 2022
    Date of Event
    May 12, 2021
    Report Date
    May 12, 2021
    Manufacturer
    SUNSTAR AMERICAS INC.
    Product Code
    JES
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR REPORT IS GENERATED RETROSPECTIVELY BASED ON COMPLAINTS AUDIT.

    Description of Event or Problem · 0

    CONSUMER CALLED TO SAY THEY USED THE ADVANCED CARE FLOSSERS AND IT DAMAGED THEIR TOOTH. DENTIST SENT ALONG A LETTER CONFIRMING THE TOOTH WAS CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433854 ADVANCED CARE FLOSSERS FLOSS, DENTAL JES SUNSTAR AMERICAS INC. 888BC

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other