BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENTEK ULTIMATE DENTAL GUARD

    MDR report key: 21881023 · Received April 22, 2025

    Report

    Report Number
    1719513-2025-00006
    Event Type
    Injury
    Date Received
    April 22, 2025
    Manufacturer
    MEDTECH HOLDINGS, INC.
    Product Code
    OBR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    INITIAL (19-NOV-2024): THIS CASE REPORTED VIA TELEPHONE REFERS TO AN 18 YEAR OLD MALE WITH AN WHOSE CONCOMITANT MEDICATIONS AND ALLERGIES WERE NOT REPORTED. THE CONSUMER'S MOTHER REPORTED THAT HE SON WORE THE DENTEK ULTIMATE DENTAL GUARD FOR TEETH GRINDING AND EXPERIENCED CROOKED TEETH. SHE REPORTED THAT HER SON HAD BEEN WEARING THE GUARD FOR "A FEW MONTHS" BUT HAD USED THE ULTIMATE DENTAL GUARD PREVIOUSLY. FOLLOW UP (24-MAR-2025): THE COMPANY RECEIVED A DOCTORS NOTE FROM THE TREATING DENTIST WHICH SHOWED INDICATED THE CONSUMER HAS WORN THE NIGHT GUARDS FOR 2 YEARS AND WAS DIAGNOSED WITH CLASS 1 MALOCCLUSION, SEVERE ANTERIOR OPEN BITE. THE DENTIST RECOMMENDED FULL BONDED ORTHODONTIC TREATMENT OR INVISALIGN, COUPLES WITH TEMPORARY ANCHORAGE DEVICES (TAD'S) PLACED ON THE MAXILLARY ARCH. THE CASE WAS UPDATED TO SERIOUS/REPORTABLE. THIS CASE OUTCOME IS NOT RECOVERED/ NOT RESOLVED. MEDDRA VERSION 27.1 EXPECTEDNESS: MALOCCLUSION: EXPECTED OFF LABEL USE. ACCORDING TO THE COMPANY REFERENCE SAFETY INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1353615 DENTEK ULTIMATE DENTAL GUARD MOUTHGUARD, OVER-THE-COUNTER OBR MEDTECH HOLDINGS, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Male Other| S| R