INVISALIGN CLEAR ALIGNERS AND INVISALIGN 'ALTERNATIVE MANUFACTURING PROCESS,CLEA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-30 for INVISALIGN CLEAR ALIGNERS AND INVISALIGN 'ALTERNATIVE MANUFACTURING PROCESS,CLEA manufactured by Align Technology Inc..

Event Text Entries

[177401643] Pt undergoing treatment with invisalign aligners. Experienced burning sensation on her tongue and metallic taste in her mouth after initial aligner delivery. Invisalign replaced aligners with 'alternate mfg process' and symptoms continued. She discontinued aligner wear, and symptoms persisted for several weeks, including significant alteration of taste sensation. After abatement of symptoms, she transitioned to 3m clarity aligners, and has been asymptomatic since. She was treated by an oral medicine specialist, and was treated with a steroid and an anti-fungal medication. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5092661
MDR Report Key9653679
Date Received2020-01-30
Date of Report2020-01-28
Date of Event2019-11-20
Date Added to Maude2020-01-31
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 NameINVISALIGN CLEAR ALIGNERS AND INVISALIGN 'ALTERNATIVE MANUFACTURING PROCESS,CLEA
Generic NameALIGNER, SEQUENTIAL
Product CodeNXC
Date Received2020-01-30
Returned To Mfg2019-11-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerALIGN TECHNOLOGY INC.
Manufacturer AddressSAN JOSE CA US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-01-30

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