INVISALIGN SYSTEM INVISALIGN SYSTEM - LITE 8852

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-01-14 for INVISALIGN SYSTEM INVISALIGN SYSTEM - LITE 8852 manufactured by Align Technology, Inc..

Event Text Entries

[178333397] No conclusive evidence has been provided that supports or opposes that fact that the invisalign system aligners caused or contributed to the patients symptoms. This event is being filed as an mdr as this event appears to have been potentially serious in nature or life threatening to the patient, and an align product was being used.
Patient Sequence No: 1, Text Type: N, H10


[178333398] The patient reported symptoms of glottic edema (swollen vocal cords), swollen lips, sore mucosa and burning sensation. The patient reported visiting the emergency room due to the reported symptoms. The patient reported being prescribed anti-allergy medication (unspecified) to alleviate the reported symptoms. The treatment was discontinued on (b)(6) 2019 and the patient is currently getting better.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2953749-2019-03795
MDR Report Key9588943
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2020-01-14
Date Mfgr Received2019-12-17
Device Manufacturer Date2019-09-06
Date Added to Maude2020-01-14
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 95134
Manufacturer CountryUS
Manufacturer Postal95134
Manufacturer Phone4087891588
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINVISALIGN SYSTEM
Generic NameALIGNER, SEQUENTIAL
Product CodeNXC
Date Received2020-01-14
Model NumberINVISALIGN SYSTEM - LITE
Catalog Number8852
Lot Number30949119
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 95134 US 95134


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening 2020-01-14

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