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

Model Number INVISALIGN SYSTEM - COMPREHENSIVE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Anaphylactic Shock (1703)

Event Date 09/01/2020

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 an anaphylactic reaction while an invisalign product was being used.

Event Description

The patient reported the symptom of anaphylactic episode.The patient reported having visited the emergency room due to the reported symptom.It is unknown if medications were taken or prescribed to alleviate the reported symptom.The treatment was discontinued on 09/16/2020, but the condition has not improved.

• Brand Name: INVISALIGN SYSTEM
• Type of Device: SEQUENTIAL ALIGNER
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC; 2820 orchard parkway; san jose CA 95134
• Manufacturer (Section G): ALIGN TECHNOLOGY, INC; 2820 orchard parkway; san jose CA 95134
• Manufacturer Contact: nestor vazquez ; 2820 orchard parkway; san jose, CA 95134 ; 4084701480
• MDR Report Key: 11089379
• MDR Text Key: 224149261
• Report Number: 2953749-2020-03318
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• 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: 8820
• Device Lot Number: 35446227
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/30/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/17/2020
• 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): Other
• Patient Age: 59 YR