BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUM SOFT-PICKS ADVANCED MINT

    MDR report key: 12011764 · Received June 16, 2021

    Report

    Report Number
    0001413787-2021-00009
    Event Type
    Injury
    Date Received
    June 16, 2021
    Date of Event
    April 7, 2021
    Report Date
    April 14, 2021
    Manufacturer
    SUNSTAR AMERICAS INC.
    Product Code
    JET
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CORRECTIONS TO THE ORIGINAL MDR SUBMITTED ARE AS FOLLOWS: 3. SECTION B.4. - CORRECTED DATE OF REPORT - 04/14/2021. 4. SECTION D.2. - CORRECTED PRODUCT CODE TO JET. 5. SECTION G.3. - CORRECTED DATE RECIEVED Y MANUFACTURER - 04/14/2021. 6. SECTION G.7. - ADDED ADVERSE EVENT TERMS - STUCK IN THROAT. 7. SECTION H.1. - CORRECTED TO SERIOUS INJURY. 8. SECTION H.6. - ADDED PROBLEM CODES - 3615, 4614, 2396.

    Description of Event or Problem · 0

    THE TIP OF THE ADVANCED SOFT-PICK BROKE OFF AND GOT STUCK IN PATIENT'S THROAT. SHE HAS TRIED EATING, DRINKING AND GARGLING, BUT IT WAS STILL THERE THE NEXT DAY. WENT TO THE EMERGENCY ROOM, TOOK X-RAYS, AND TREATED FOR THROAT IRRITATION.

    Description of Event or Problem · 1

    THE TIP OF THE ADVANCED SOFT-PICK BROKE OFF AND GOT STUCK IN PATIENT'S THROAT. SHE HAS TRIED EATING, DRINKING AND GARGLING, BUT IT WAS STILL THERE THE NEXT DAY. WENT TO THE EMERGENCY ROOM, TOOK X-RAYS, AND TREATED FOR THROAT IRRITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910685 GUM SOFT-PICKS ADVANCED MINT PICK, MASSAGING JET SUNSTAR AMERICAS INC. 1680AL
    910687 GUM SOFT-PICKS ADVANCED MINT PICK, MASSAGING JET SUNSTAR AMERICAS INC. 1680AL

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Other| H TIMOLOL, LATANOPROST