INVISIBLE ALIGNERS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-11 for INVISIBLE ALIGNERS manufactured by Smile Direct Club / Align Technology, Inc..

Event Text Entries

[183470941] I received my aligners from smile direct club around (b)(6) 2019, as i was hoping to straighten my teeth before my wedding day. My first set of aligners were tight as to be expected, but my mouth broke out into terrible cold sores. I couldn't eat or sleep but i continued to wear all day and night. I want to put in my second set of aligners for week 2 and they did not fit. When bringing this to customer service. I could not get anyone to consistently talk to. I was passed from person to person until finally someone told me to switch over to my week 3 aligners. I asked how on earth week 3 would fit me when week 2 did not but i was dismissed. I did as i was told, of course those aligners did not fit, and when going back to customer service i got passed around with no resolution. I finally walked into a physical store with my box of product and told them to get me on the phone with someone who could help me and just give me a refund, as i figured out the product was complete hoax. It took weeks to get everything resolved, and it wasn't until i threatened blowing up their social media and going to bbb that my refund got processed. Thankfully i got out before i had any long term damage done, but my brother inlaw is an orthodontist and has said how many new pts he has received with irreversible damage. I am now two months away from my wedding with crooked button teeth because i was so fooled by this fraud company. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5093693
MDR Report Key9823660
Date Received2020-03-11
Date of Report2020-03-09
Date of Event2020-01-01
Date Added to Maude2020-03-12
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINVISIBLE ALIGNERS
Generic NameALIGNER, SEQUENTIAL
Product CodeNXC
Date Received2020-03-11
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSMILE DIRECT CLUB / ALIGN TECHNOLOGY, INC.


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-11

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