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

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

Patient Problems Dyspnea (1816); Pain (1994); Swollen Lymph Nodes/Glands (4432); Swelling/ Edema (4577)

Event Date 03/30/2022

Event Type  Injury  

Event Description

I am using invisalign.I woke up in the middle of the night struggling to breathe and with severe pain and swelling in my mouth, throat, neck, and lymph nodes.I should have gone to the er immediately, but did not.I removed the aligners and the swelling went down hours later, but 16+ hours later i'm having discomfort and pain.I never put them back in because i was fearful my reaction would potentially be deadly.I was in anaphylaxis.Fda safety report id# (b)(4).

• Brand Name: INVISALIGN ALIGNERS
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.
• MDR Report Key: 13995826
• MDR Text Key: 288620703
• Report Number: MW5108735
• 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: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other; Life Threatening
• Patient Age: 27 YR
• Patient Sex: Female
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White