SMILE DIRECT CLUB

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-21 for SMILE DIRECT CLUB manufactured by Smile Direct Club / Align Technology, Inc..

MAUDE Entry Details

Report NumberMW5091228
MDR Report Key9362586
Date Received2019-11-21
Date of Report2019-11-20
Date of Event2019-10-24
Date Added to Maude2019-11-22
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSMILE DIRECT CLUB
Generic NameALIGNER SEQUENTIAL
Product CodeNXC
Date Received2019-11-21
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerSMILE DIRECT CLUB / ALIGN TECHNOLOGY, INC.
Manufacturer AddressTN 37219 US 37219


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-11-21

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