inforMED
InjuryOYH

C-SHAPED VIBRATION DEVICE

Received Sep 29, 2025 · Event occurred Jul 1, 2024

Report MW5176703 · MDR key 23167922

Device

Generic name

Orthodontic Vibratory Accessory

Manufacturer

Dentsply Llc

Model number

ASM-20018

Lot number

011521-00004

Product problems

  • Failure to Charge
  • Therapeutic or Diagnostic Output Failure

Patient

45 YR · Female

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

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.