BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUM® SOFT-PICK® ORIGINAL 80CT

    MDR report key: 23363265 · Received October 22, 2025

    Report

    Report Number
    1413787-2025-00239
    Event Type
    Injury
    Date Received
    October 22, 2025
    Date of Event
    September 22, 2025
    Report Date
    October 22, 2025
    Manufacturer
    SUNSTAR AMERICAS, INC.
    Product Code
    JET
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    CUSTOMER USED SUNSTAR DENTAL PICK AS WHILE DOING BETWEEN THEIR BACK MOLAR, THE PICK BROKE OFF AND WAS STUCK IN BETWEEN MY TEETH. CUSTOMER SPENT OVER AN HOUR TRYING TO REMOVE IT. THEY WENT TO A NURSING STATION IN RETIREMENT HOME FOR ASSISTANCE. THEY WERE UNSUCCESSFUL IN PULLING IT OUT WITH TWEEZERS. THE NEXT DAY IT WAS REMOVED. THE CUSTOMER SUSTAINED PAIN IN THEIR JAW, TEARING TO THE SKIN AT BOTH CORNERS OF HER MOUTH, BLEEDING, AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243331 GUM® SOFT-PICK® ORIGINAL 80CT SOFT PICKS JET SUNSTAR AMERICAS, INC. 632A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention