BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUM BRAND DEEP CLEAN TOOTHBRUSH

    MDR report key: 14349750 · Received May 10, 2022

    Report

    Report Number
    0001413787-2022-00148
    Event Type
    Malfunction
    Date Received
    May 10, 2022
    Date of Event
    October 12, 2020
    Report Date
    October 12, 2020
    Manufacturer
    SUNSTAR AMERICAS INC.
    Product Code
    EFW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 BOUGHT A PACKAGE OF THE GUM DEEP CLEAN TOOTHBRUSHES AND THE BRISTLES HAVE FALLEN OUT IN HER MOUTH EVERY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1239516 GUM BRAND DEEP CLEAN TOOTHBRUSH TOOTHBRUSH, MANUAL EFW SUNSTAR AMERICAS INC. 525PH

    Patients

    Seq Age Sex Outcome Treatment
    1 Female