INVISALIGN ORTHODONTIC APPLIANCE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-07-11 for INVISALIGN ORTHODONTIC APPLIANCE manufactured by Align Technologies.

Event Text Entries

[3654949] I am a pt, (b)(6) female, that has been using invisalign since (b)(6) 2011, currently on 3rd ste of trays, 2 revisions. In (b)(6) 2012, i began to experience symptoms of inflammation in several areas of my body. I associated it with menopause and sought treatment for each of these symptoms. I experienced keratitis concurrently with what i suspected to be tennis elbow. Antibiotics for the eye and corticosteroid injection for the elbow. In (b)(6) 2012, i began to experience knee pain, which ended up in injections of hyaluronic acid for both knees. All this time, i suffered from extremely dry eyes requiring the use of lubricating ointment at night. In (b)(6) 2012, i developed recurrent effusions of the right knee. After several visits to different orthopaedics and no relief, i sought treatment with a rheumatologist. Diagnosis was spondyloarthritis which was not totally responsive to celebrex. I have since visited a do who is an alternative practitioner and was tested for lyme as well as testing of allergies. In looking for clues, he did a complete medical history timeline. He tested the invisalign retainer i was wearing at the time, electric acupuncture machine, and it turned out i was sensitive to the materials in the retainer. To test this, i did not wear the retainer for 1 week. I felt so much better with pain lessening by the day and my knee was normal. As soon as i tried the retainer, all it took was sleeping with it and removing it at lunch time the next day, my knee is swollen and my elbow is painful to touch again. Event abated after use stopped or does reduced: yes. Event reappeared after reintroduction: yes.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5030885
MDR Report Key3231304
Date Received2013-07-11
Date of Report2013-07-11
Date of Event2012-05-24
Date Added to Maude2013-07-18
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameINVISALIGN ORTHODONTIC APPLIANCE
Generic NameINVISALIGN
Product CodeKMY
Date Received2013-07-11
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerALIGN TECHNOLOGIES
Manufacturer AddressSAN JOSE CA US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2013-07-11

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