BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUM PROXABRUSH GO-BETWEEN

    MDR report key: 11899072 · Received May 27, 2021

    Report

    Report Number
    0001413787-2021-00007
    Event Type
    Injury
    Date Received
    May 27, 2021
    Date of Event
    February 15, 2021
    Report Date
    February 22, 2021
    Manufacturer
    SUNSTAR AMERICAS INC.
    Product Code
    EFW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CORRECTIONS TO THE ORIGINAL MDR SUBMITTED ARE AS FOLLOWS: 1. SECTION A.2. - ADDED AGE AND DOB. 2. SECTION B.3. -ADDED DATE OF EVENT- 02/15/2021. 3. SECTION B.4. - CORRECTED DATE OF REPORT - 02/22/2021. 4. SECTION E-1 - ADDED INITIAL REORTER INFORMATION. 5. SECTION G.3 - CORRECTED DATE RECIEVED BY MANUFACTURER - 2/22/2021. 6. SECTION G.7. - ADDED ADVERSE EVENT TERM - BRISTLES STUCK BETWEEN GUMS. 7. SECTION H.6. - ADDED ADVERSE PROBLEM CODES - 3165, 3190, 4614.

    Description of Event or Problem · 0

    CONSUMER USED THE PRODUCT AND WAS HAVING SEVERE PAIN FOR A WEEK. SHE WENT TO THE DENTIST, WHO FOUND A BRISTLE STUCK IN HER GUMS BY THE BOTTOM RIGHT MOLAR. NO OTHER "INFORMATION" WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    NO FILES ATTACHED.

    Description of Event or Problem · 1

    CONSUMER USED THE PRODUCT AND WAS HAVING SEVERE PAIN FOR A WEEK. SHE WENT TO THE DENTIST, WHO FOUND A BRISTLE STUCK IN HER GUMS BY THE BOTTOM RIGHT MOLAR. NO OTHER INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792763 GUM PROXABRUSH GO-BETWEEN TOOTHBRUSH, MANUAL EFW SUNSTAR AMERICAS INC. 872FC

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Other