INVISALIGN SYSTEM - COMPREHENSIVE

Additional Manufacturer Narrative

THE CURRENT INSTRUCTIONS FOR USE CONTAINS THE FOLLOWING: "WARNINGS- IN RARE INSTANCES, SOME PATIENTS MAY BE ALLERGIC TO THE PLASTIC ALIGNER MATERIAL.". THE TREATING DOCTOR SHARED THAT THE POTENTIAL ROOT CAUSE COULD HAVE BEEN THE DISINFECTANT SOLUTION USED IN POST-PROCESSING. THERE IS NO CONCLUSIVE INFORMATION REGARDING EMERGENCY DEPARTMENT INTERVENTIONS, LABORATORY TESTING, OR FINAL DIAGNOSIS. THERE IS NO CONCLUSIVE EVIDENCE PROVIDED THAT SUPPORTS OR OPPOSES WHETHER THE INVISALIGN SYSTEM CAUSED OR CONTRIBUTED TO THE REPORTED LIFE-THREATENING AND MEDICAL INTERVENTION. BASED ON THE AVAILABLE INFORMATION, THE PATIENT HAD LIFE-THREATENING AND MEDICAL INTERVENTION, AND THE INVISALIGN SYSTEM WAS BEING USED. THEREFORE, AN MDR WILL BE FILED IN THE UNITED STATES PER 21 CFR 803.

Description of Event or Problem

THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD SYMPTOMS OF HIVES, DIFFICULTY BREATHING, DIZZINESS, SWEATING, AND ABDOMINAL PAIN. THE PATIENT HAS A DOCUMENTED HISTORY OF LEGUME FOOD ALLERGIES AND CARRIES AN EPIPEN (EPINEPHRINE AUTO-INJECTOR). THE PATIENT REPORTED VISITING THE EMERGENCY ROOM AND REQUIRED MEDICAL INTERVENTION CONSISTING OF EMERGENCY EVALUATION FOLLOWING SELF-ADMINISTRATION OF EPINEPHRINE. THE PATIENT INDICATED TAKING EPIPEN (EPINEPHRINE) TO ALLEVIATE THE REPORTED SYMPTOMS. IT IS UNKNOWN IF THE PATIENT WAS PRESCRIBED OR TOOK ANY ADDITIONAL MEDICATIONS. IT IS UNKNOWN IF ANY CLINICAL OR LABORATORY TESTS WERE PERFORMED. THE TREATMENT WAS DISCONTINUED ON (B)(6) 2026 AND THE PATIENT IS CURRENTLY ASYMPTOMATIC