HEALTHY START
Received May 31, 2022 · Event occurred Aug 1, 2021
Report MW5110008 · MDR key 14565985
Device
Generic name
Band, Preformed, Orthodontic
Manufacturer
Ortho-tain, IncProduct problems
- Product Quality Problem
Patient
9 YR · Male
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Description of Event or Problem
THE DENTIST TOLD ME TO GET BOTH CHILDREN IN THE HEALTHY START MOUTHGUARD PROGRAM. HE CLAIMED IT WILL FIX THEIR ORTHODONTIC PROBLEMS. AFTER SPENDING THOUSANDS ON THESE DEVICES, MY SON'S GUMS BECAME VERY IRRITATED AND MORE HARM THEN GOOD WAS DONE BY THESE DEVICES. THE COMPANY HAS NO EVIDENCE THAT IT TREATS THE ORTHODONTIC ISSUES AND IT TELLS PATIENTS IT WILL FIX THE PROBLEMS WITHOUT EVIDENCE. THE COMPANY IS PRYING ON PARENTS THAT WANT TO BE PROACTIVE ON THEIR KIDS. AFTER SPEAKING WITH MULTIPLE ORTHODONTISTS, THEY CONCUR THIS DEVICE MAKES FALSE CLAIMS AND I THINK. PLEASE INVESTIGATE THIS DEVICE BEFORE THEY CONTINUE TO SCAM THOUSANDS OF PARENTS. (B)(6). FDA SAFETY REPORT ID# (B)(4).