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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Tissue Breakdown (2681); Swelling/ Edema (4577)

Event Date 03/21/2022

Event Type  Injury  

Event Description

Woke up the morning of (b)(6) 2022 with noticeable swollen upper and lower lips along with pain of the lips, mouth, and tongue.On further inspection, i noticed i had canker sores on the inside of my cheeks.As the week progressed the sores became more painful and spread to my inner lips and all areas of my tongue.I presented to my orthodontist as i had started invisalign about 4 weeks prior and thought that this could be a possible cause.The orthodontist confirmed that these symptoms were a reaction to a component of the invisalign.Later in the week, i presented to urgent care for symptom relief and management.I was prescribed antibiotics, antivirals, steroids, and lidocaine for pain in the mouth.Fda safety report id # (b)(4).

• Brand Name: INVISALIGN
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.
• MDR Report Key: 13949724
• MDR Text Key: 288312284
• Report Number: MW5108612
• 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: 03/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/29/2022
• Patient Sequence Number: 1
• Treatment: ALLEGRA OTC; LEXAPRO 5MG ; MIRENA IUD; OMEGA 3 ; PROBIOTIC ; VITAMIN D3
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White