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 Problem Swelling/ Edema (4577)

Event Date 09/01/2021

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 requiring an epipen while an invisalign product was being used.

Event Description

The patient reported symptoms of difficulty breathing, swollen jaw, tongue, gums, and eyes, difficulty swallowing, stiff and stinging jaw and mouth.The patient reported visiting a physician, an allergist and a rheumatologist to alleviate the reported symptoms.The patient reported being prescribed benadryl (antihistamine), allergy pills (unspecified) and an epi-pen (epinephrine) to alleviate the reported symptoms.The treatment was discontinued on (b)(6) 2021.The treating doctor shared the potential root cause could have been an allergic reaction.

• Brand Name: INVISALIGN SYSTEM
• Type of Device: SEQUENTIAL ALIGNERS
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.; 2820 orchard parkway; san jose CA 95134
• MDR Report Key: 12677481
• MDR Text Key: 281530430
• Report Number: 2953749-2021-03091
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): N
• PMA/PMN Number: K181739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 10/18/2021

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: 8824
• Device Lot Number: 203769575
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/22/2021
• Initial Date FDA Received: 10/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR