MAUDE Adverse Event Report: ALIGN TECHNOLOGY, INC. INVISALIGN PLASTIC TRAYS FOR ORTHODONTIC TREATMENT; ALIGNER, SEQUENTIAL

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Abscess (1690); Gastritis (1874); Headache (1880); Nausea (1970); Pain (1994); Cramp(s) (2193); Sleep Dysfunction (2517); Constipation (3274)

Event Type  Injury  

Event Description

On (b)(6) 2019: began invisalign orthodontic treatment; got my 4 months¿ supply of invisalign trays.On (b)(6) 2019: gastritis throughout entire day followed by cramps.On friday evening migraines and nausea.On friday night - mid and lower abdominal pain and cramping along with migraines and unable to sleep well.Still had the invisalign trays on for 22 hours.On (b)(6) 2019 morning, constipated and still in pain.The taste of the invisalign plastic is becoming more noticeable and a dry mouth.Stayed in bed all day but thinking about going to the hospital even though i did not have accrued sick time due to new job.Kept invisalign trays on for 21 hours.Could not sleep well due to cramps and pain when i moved in bed.On (b)(6) 2019 morning 4am, began to research the invisalign product regarding stomach pain and found a post on the internet about a person who had to stop the treatment due to constipation.Then found a different post referring to a maude website report (fda.Gov) warning about serious allergic reactions reported by people and the possible underreporting of incidents.I removed the invisalign trays sunday at 6am to see what kind of response i would experience.I rinsed my mouth and lied down in bed and began to massage my stomach for 15 mins where it hurt then fell asleep.Got up at 8 am and tried going to the bathroom unsuccessfully.Forced some papaya fruit and drank a probiotic smoothie around 8:30 am.At 10:30 am tried to go to the bathroom again and was able although not too productive but a good sign.At approx.2pm, was able to go to the bathroom a second time.Sharp stomach pain was still present around belly button, lower abdomen and around bladder but there were signs of improvement.On (b)(6) 2010 at 3:00 pm went to grocery store and bought more papaya and drank another smoothie.On (b)(6) 2010 at 5:00 pm ate solid food.On sunday night slept much better although still with stomach pain around belly button and bladder.Continued massaging stomach area while lying down.On (b)(6) 2019, 10 am able to have a better bowel movement.Still pain and irritation in abdomen.On (b)(6) 2019, i called (b)(6) and spoke with dentist assistant to advise of my terrible experience and that i had to discontinue inserting the invisalign trays.Dentist assistant scheduled me for an appt at 4 pm for same day; (b)(6) 2019, 4 pm - spoke with dentist and explained why i had to stop using the invisalign trays.She asked if i was eating food with them on, or if i maybe had eaten something that could have caused the stomach pains, or if i had contracted a stomach virus.My answer was a definite no.On (b)(6) 2019 - began experiencing similar stomach pains but accompanied with sharp stabs in my lower abdomen and pelvic area.I did not have enough vacation or sick time accrued, so decided to hold off going to hospital hoping symptoms would go away again by eating fruits, vegetables, and smoothies.On (b)(6) 2019 - still same symptoms, so i left work at 2 pm and went to an urgent medical care facility which recommended i go to the hospital due to preliminary sigmoidal perforation.At the hospital the cat scan with contrast showed several diverticula involving the sigmoid colon with colonic wall thickening and adjacent inflammatory stranding involving the distal sigmoid colon, suggesting acute diverticulitis.There is an adjacent 1.8 x 1.3 cm fluid and air density collection in the left pelvis, suggesting a small pericolonic abscess.The right seminal vesicle appears atrophic.There is no evidence of acute bowel obstruction.I was admitted at the hospital and treated intravenously with antibiotics and a liquid diet on (b)(6) 2019; a picc line was inserted to be used to administer antibiotic treatment intravenously until (b)(6) 2019.On (b)(6) 2019, i was discharged from the hospital.The surgeon has recommended surgery in 5 years due to colon perforation.On (b)(6) 2019 blood work thus far shows no infection.The purpose of this report is to create awareness for people with potential allergic reaction which i had.The product may be a good alternative for many other people who prefer less maintenance in their orthodontic treatment.There should be a test done and add'l warnings regarding potential gastrointestinal problems.The change in my taste buds and saliva composition was my first warning but i ignored it.

• Brand Name: INVISALIGN PLASTIC TRAYS FOR ORTHODONTIC TREATMENT
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.
• MDR Report Key: 8523225
• MDR Text Key: 142474138
• Report Number: MW5085942
• 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: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 60 YR
• Patient Weight: 57