BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-SHAPED VIBRATION DEVICE

    MDR report key: 23167922 · Received September 29, 2025

    Report

    Report Number
    MW5176703
    Event Type
    Injury
    Date Received
    September 29, 2025
    Date of Event
    July 1, 2024
    Report Date
    September 23, 2025
    Manufacturer
    DENTSPLY LLC
    Product Code
    OYH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE PROPEL ORTHODONTICS C-SHAPED VIBRATION DEVICE REF ASM-20018, LOT 011521-00004, MFG. DATE 2021-01-15, FAILED TO HOLD A CHARGE AND DID NOT WORK AS INTENDED (LACK OF EFFECT). WHEN CALLING THE COMPANY THEY DID NOT WANT TO TAKE A COMPLIANT AND SAID THERE IS NOTHING THEY CAN DO AND THEY DO NOT STAND BY THE QUALITY OF THEIR MEDICAL DEVICES. ADDITIONALLY, THE PHONE NUMBER ON THE LABEL IS NOT CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1839397 C-SHAPED VIBRATION DEVICE ORTHODONTIC VIBRATORY ACCESSORY OYH DENTSPLY LLC ASM-20018 011521-00004

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female