BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUMMIT PLUS SENSITIVE COMPACT TOOTHBRUSH

    MDR report key: 14349807 · Received May 10, 2022

    Report

    Report Number
    0001413787-2022-00137
    Event Type
    Malfunction
    Date Received
    May 10, 2022
    Date of Event
    September 11, 2019
    Report Date
    September 11, 2019
    Manufacturer
    SUNSTAR AMERICAS INC.
    Product Code
    EFW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 WAS USING THE GUM SUMMIT PLUS SENSITIVE TOOTHBRUSH AND THE BRISTLES STARTED TO COME OUT IN HIS MOUTH CAUSING HIM TO GAG ON THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1239523 SUMMIT PLUS SENSITIVE COMPACT TOOTHBRUSH TOOTHBRUSH, MANUAL EFW SUNSTAR AMERICAS INC. 509P

    Patients

    Seq Age Sex Outcome Treatment
    1 Male