MAUDE Adverse Event Report: ALIGN TECHNOLOGY INC. INVISALIGN ALIGNERS; ALIGNER, SEQUENTIAL

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fatigue (1849); Hypersensitivity/Allergic reaction (1907); Low Blood Pressure/ Hypotension (1914); Inflammation (1932); Burning Sensation (2146); Sore Throat (2396)

Event Date 12/26/2020

Event Type  Injury  

Event Description

By the fourth day of continuous wear of my first set of invisalign aligners (12/26/20), i experienced extreme generalized fatigue for several hours, a sore throat, and what felt like a thickening of my tongue and lips.The sore throat felt different from any throat inflammation i've had it didn't make deglutition more difficult, felt like something burning (as distinct from duller kinds of pain), and extended to the back of my palate.As for the sensation of fatigue, the closest comparison that comes to mind is an extended spell of low blood pressure (without, however, feeling exactly like one).Thinking i might be having an allergic reaction to the plastic, i decided to discontinue use for about two days, during which all my symptoms gradually disappeared.In order to have a sense of the aligners' probable effects on a reduced wearing time, i then decided to resume wearing them for a few more days, but only overnight.At the end of the first night, i had again the same kind of sore throat (though weaker), which disappeared over the morning.This sore throat wasn't associated with any other symptoms.With each night of wear, however, my morning sore throat grew again more painful.An additional symptom which at first, i didn't relate to invisalign, but which in retrospect i can only link to the aligners, was quick bright flashes in the right corner of my field of vision.These looked like small shining halfmoons sliding for a second or less across that region of my field of vision, and then disappearing.I began experiencing them several times a day during the first days of continuous wear; while wearing the aligners only at night, they decreased in frequency, but i still didn't suppose they might be related to the other symptoms, as i imagined they might be due to some non-dangerous form of vitreous syneresis.Since discontinuing invisalign completely, however, these odd visual flashes have entirely disappeared, like all my other symptoms.Fda safety report id # (b)(4).

• Brand Name: INVISALIGN ALIGNERS
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY INC.
• MDR Report Key: 11163256
• MDR Text Key: 227034505
• Report Number: MW5098789
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 29 YR
• Patient Weight: 51