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

Model Number INVISALIGN SYSTEM - COMPREHENSIVE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 03/21/2023

Event Type  Injury  

Manufacturer Narrative

The current instructions for use (ifu) pn contains the following: "warning - in rare instances, some patient may be allergic to the plastic aligner material, discontinue use and consult a health care professional immediately." a potential root cause was not provided.This event is being filed as an mdr since the patient reported two hospitalizations and there was inconclusive evidence regarding the involvement of the invisalign system aligners.

Event Description

The patient reported symptoms of tingling, itchiness and an immune response that may lead to her losing her breast implants.The patient reported wearing two holter monitors and having two hospitalizations.The patient did not report being prescribed any medication to alleviate the reported symptoms but reported taking zyrtec and cortisone cream over the counter.It is unknown if the patient is continuing the use of the aligners.

• Brand Name: INVISALIGN SYSTEM
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.; 2820 orchard parkway; san jose CA 95134
• Manufacturer Contact: aaheli poddar ; 2820 orchard parkway; san jose, CA 95134 ; 4084701340
• MDR Report Key: 16765619
• MDR Text Key: 313541716
• Report Number: 2953749-2023-01069
• Device Sequence Number: 1
• Product Code: NXC
• UDI-Device Identifier: 00816063020189
• UDI-Public: (01)00816063020189(10)0132142857(13)221020(91)1485120810N
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• 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: 9000
• Device Lot Number: 132142857
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2022
• 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): Hospitalization
• Patient Age: 53 YR
• Patient Sex: Female