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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Memory Loss/Impairment (1958); Pain (1994); Burning Sensation (2146); Arthralgia (2355)

Event Date 07/01/2017

Event Type  Injury  

Event Description

Pt reported that she started wearing invisalign aligner about 2 years ago and she was experiencing extreme fatigue, joint pain, memory loss, sore throat and coughing every morning.Even though she was not sure if the symptoms were directly related to the invisalign, she says that is the only change she made from her routine.She also said she started wearing them part time for the next 7 to 8 months.She went back wearing them full time for the past 3 weeks and she started experiencing more fatigue, dryness of mouth throat, burning sensation on chest, mouth and throat.

• Brand Name: INVISALIGN ALIGNER
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.
• MDR Report Key: 8896603
• MDR Text Key: 154554631
• Report Number: MW5089059
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): N
• 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: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 71