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

Patient Problems Abdominal Pain (1685); Headache (1880); Muscle Weakness (1967); Dizziness (2194); Anxiety (2328); Cognitive Changes (2551); Confusion/ Disorientation (2553); Balance Problems (4401); Increased Sensitivity (4538); Swelling/ Edema (4577)

Event Date 12/15/2023

Event Type  malfunction  

Event Description

Time line of my reaction to invisalign is as follows: my lips got swollen/chapped from invisalign, i gave myself a little break from the invisalign to no avail.Headaches, pelvic pain, feeling weird, not only did i'd experienced the above i was not able to touch my face not even a simple gentle stroke, also i was feeling discomfort in my chest as well.Dental appointment (b)(6) 2023 my first invisalign tray, reaction two days later is as follows.First sign of symptoms was on (b)(6) 2023 pain, lower left side of my pelvic area, lasted a little over a week.Once the pain subsided, i'd tried again only to feel lightheaded, removed the invisalign tray until my next dental appointment.Follow-up dental appointment, had the tray placed back in on wednesday,(b)(6) to see if the symptoms returned and it did, 7:50 pm approximately 8 hours after my visit i felt lightheaded slightly off balance, decided to relax and went to bed, watched some television till i fell asleep with the invisalign still in my mouth.Thursday, (b)(6) 2024 7:50 am i started to experience a sharp pain in my lower left side of my pelvic area again similar to several weeks ago when invisalign was in place accompanied with a headache, immediately i removed the invisalign clearly, it's not for me.(b)(6) evening hours i was feeling lightheaded, confused and weak told my husband if i say take me to the hospital, i mean it.Had to confirm he fully understood my predicament, and he agreed.Thought i was going into shock, i believe i had low blood pressure, fortunately after several hours i started to feel little better.Very scary moment.(b)(6) 2024 10:30 am i had an appointment for a pap smear thankfully the results were negative.Friday, (b)(6) around 1:30 pm i developed a headache later turned into a full-blown migraine headache lasted until 3:00 am (b)(6) 2024, i had a pelvic ultrasound without doppler done per my gyn dr.(b)(6) request.Results were good.(b)(6) 2024 12:00pm pain is just about gone.P.S.I'd paid in full (b)(6) in cash and i haven't been reimbursed from my dentist.I feel i'm being ignored.

• Brand Name: INVISALIGN
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.
• MDR Report Key: 18622771
• MDR Text Key: 334438972
• Report Number: MW5150954
• 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: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Sex: Female