INVISALIGN VIVERA RETAINER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-01 for INVISALIGN VIVERA RETAINER manufactured by Align Technology Inc..

Event Text Entries

[140881841] Five days ago, i stopped wearing my vivera retainers (made by invisalign technologies) because i realized that my worsening facial rosacea, worsening ocular rosacea, two episodes of contact dermatitis, and progressively worsening gum inflammation and mouth ulcers, all occurred after i started wearing the retainers in late (b)(6) 2018 (upon the completion of my orthodontic treatment). Since ceasing to wear the retainers, there are perceptible positive changes. For example, i no longer spontaneously bleed from the front of my palate for no reason, i no longer feel the need to limit myself to soft foods, i can waterfloss with much less pain, and i can feel that the ulcers on the root of my mouth are less swollen and are starting to heal. Here is an abridged chronology. Late (b)(6) 2018: started wearing vivera retainers, late (b)(6) 2018: rosacea (previously very mild, never required medical treatment) became sufficiently severe that in (b)(6), i saw a dermatologist, who controlled the rosacea with topical meds, late (b)(6) 2018: i started to have a sore gum between two of my left upper front teeth; mid (b)(6) 2018: my ophthalmologist expressed concern that my ocular rosacea (preexisting, previously under control) had worsened significantly, late (b)(6) 2018: the sore gum around my left upper tooth was sufficiently painful that my dentist scaled the tooth; (b)(6) 2018: i began to find my palate swollen in the mornings when i removed my retainer, and my palate / gums bled each morning; mid (b)(6) 2018: i developed what i can (in retrospect) now identify as contact dermatitis on the backs of my thighs. The evident cause was a flaking foam seat on an old desk chair. I did not seek treatment for it and it eventually healed. Mid (b)(6) 2019: bleeding and irritation on my upper front gums worsened, and i saw a periodontist. He saw that my palate swelling into the edge of the vivera retainer and he cut the edge of the retainer back. This improved my symptoms briefly. Mid (b)(6) 2019: the gum inflammation worsened and spread to more upper teeth, late (b)(6) 2019: red rash appeared on my face, roughly from temples down around chin and up to temple on other side of face, early (b)(6) 2019: saw my dermatologist, who diagnosed contact dermatitis on my face and prescribed a steroid cream, early (b)(6) 2019: went for dental cleaning. Bled copiously during the cleaning, which puzzled and concerned my dentist since i had been diligently keeping my teeth clean. He advised me to return to the periodontist, mid (b)(6) 2019: as directed, stopped using the steroid cream for my facial rash. My face was mostly clear at first, but then the rash flared back up and i was not able to control it with the steroid cream (which at that point) i was only supposed to use 2x / week). (b)(6) 2019: saw the periodontist, who taking into account the rosacea and the contact dermatitis as well as the gum inflammation, said that something - but he did not know what - was upregulating my immune system. He advised me to see a specialist on oral medicine, (b)(6) 2019. Bleeding, swelling, and tenderness of gums (and ulcers behind my top front teeth) was so bad that i was trying to eat only soft food, my gums hurt when they were at rest, and i could taste blood even when i was not cleaning my teeth, the gum pain was starting to spread to my lower teeth as well, (b)(6) 2019: thought further about my periodontist's observation linking the various inflammations, and also considered that the two episodes of contact dermatitis apparently stemmed from brief contact with synthetic (a foam seat, and an elastic band of a hat). Wondered whether the vivera retainer might be causing a problem. I stopped using the vivera retainer; (b)(6): my mouth pain, bleeding, swelling, and ulcers, which by no means, healed, are noticeably and progressively better; i can eat normal foods, no longer taste blood when not cleaning my teeth.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5085497
MDR Report Key8473827
Date Received2019-04-01
Date of Report2019-03-28
Date of Event2018-05-17
Date Added to Maude2019-04-02
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameINVISALIGN VIVERA RETAINER
Generic NameMAINTAINER, SPACE PRFORMED, ORTHODONTIC
Product CodeDYT
Date Received2019-04-01
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerALIGN TECHNOLOGY INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2019-04-01

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