INVISALIGN SYSTEM INVISALIGN SYSTEM - COMPREHENSIVE 8820

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-18 for INVISALIGN SYSTEM INVISALIGN SYSTEM - COMPREHENSIVE 8820 manufactured by Align Technology, Inc..

MAUDE Entry Details

Report Number2953749-2020-00806
MDR Report Key9850984
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-18
Date of Report2020-03-09
Date of Event2020-02-01
Date Mfgr Received2020-02-27
Device Manufacturer Date2019-07-22
Date Added to Maude2020-03-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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
Manufacturer ContactMR. RYAN HOFFMEISTER
Manufacturer Street2820 ORCHARD PARKWAY
Manufacturer CitySAN JOSE, CA
Manufacturer CountryUS
Manufacturer Phone7891588
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINVISALIGN SYSTEM
Generic NameALIGNER, SEQUENTIAL
Product CodeNXC
Date Received2020-03-18
Model NumberINVISALIGN SYSTEM - COMPREHENSIVE
Catalog Number8820
Lot Number30499999
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerALIGN TECHNOLOGY, INC.
Manufacturer Address2820 ORCHARD PARKWAY SAN JOSE, CA US


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2020-03-18

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