MAUDE Adverse Event Report: PROPEL ORTHODONTICS PROPEL VPRO5; ORTHODONTIC SETTER BAND

Model Number	ASM-20018
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	08/10/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
I have two issues to report regarding a medical device by propel orthodontics.The device is called propel vpro5.The first is that it seems this device is being given (sold) to patients by orthodontists for an unapproved purpose.I read that it was approved by the fda as "a device that vibrates to assist clear plastic aligners to fit to a patient's teeth." instead it was given to me (for additional cost) by an orthodontist to accelerate the movement of teeth during treatment with invisalign aligners.Secondly, this device is held in the mouth by biting and holding.When turned on it produces high frequency vibrations that the patient feels in the jaw and ear.Every time i use this device it immediately causes imbalance and i hear a low pitched humming sound.The imbalance is certainly related to vibrations in the fluid inside the semicircular canals (balance system) of the inner ear.In addition to the obvious imbalance effects, this device should be evaluated for effects on the inner ear cochlear hearing system which would not be immediately obvious to the patient but this could cause permanent hearing damage over time.The product packaging comes with no warnings.I find it unusual that this product would not have been tested for these harmful effects before being sold.The imbalance problem occurs immediately every time i use it.At the very least the patient should be warned about it and instructed to remain seated for the 5 minutes each day that this product is used.

• Brand Name: PROPEL VPRO5
• Common Device Name: ORTHODONTIC SETTER BAND
• Manufacturer (Section D): PROPEL ORTHODONTICS
• MDR Report Key: 6793989
• Report Number: MW5071559
• Device Sequence Number: 137473
• Product Code: ECR
• UDI-Device Identifier: 00852673007011
• UDI-Public: 00852673007011
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/13/2019
• Device Model Number: ASM-20018
• Device Lot Number: 031317-00001
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/11/2017
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 68