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

Model Number INVISALIGN SYSTEM - COMPREHENSIVE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Rash (2033); Swelling/ Edema (4577)

Event Date 02/01/2022

Event Type  Injury  

Manufacturer Narrative

No conclusive evidence has been provided that supports or opposes the fact that the invisalign system aligners caused or contributed to the reported symptom.This event is being filed as an mdr as the patient reported was hospitalized for an extended period of time and was given antihistamine (via vein injection) and the invisalign product was being used.A udi could not be provided in this report as this information was not captured in this complaint ticket.

Event Description

The patient reported symptoms of difficulty breathing and swallowing, rash, and swelling of the face, lips, and gums.The patient reported being rushed to the hospital and was hospitalized for a night, due to the reported symptoms.The patient reported having an allergy test performed and the results show that patient is allergic to plastics.The patient reported being given an antihistamine (through vein) and antihistamines (unspecified antihistamines) to alleviate the reported symptoms.The treatment was discontinued on (b)(6) 2022 and the patient is currently asymptomatic.The treating doctor shared the potential root cause could have been a reaction to the aligners.

• Brand Name: INVISALIGN SYSTEM
• Type of Device: SEQUENTIAL ALIGNERS
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.; 2820 orchard parkway; san jose CA 95134
• Manufacturer Contact: ryan hoffmeister ; 2820 orchard parkway; san jose, CA 95134 ; 4087891588
• MDR Report Key: 13911269
• MDR Text Key: 289735729
• Report Number: 2953749-2022-00600
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): N
• Reporter Country Code: MT
• PMA/PMN Number: K181739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 03/22/2022

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: INVISALIGN SYSTEM - COMPREHENSIVE
• Device Catalogue Number: 8812
• Device Lot Number: 207959871
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2022
• Initial Date FDA Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization
• Patient Age: 13 YR
• Patient Sex: Female