BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVISALIGN SYSTEM

    MDR report key: 1852482 · Received September 30, 2010

    Report

    Report Number
    2953749-2010-00077
    Event Type
    Injury
    Date Received
    September 30, 2010
    Date of Event
    August 26, 2010
    Report Date
    September 30, 2010
    Manufacturer
    ALIGN TECHNOLOGY INC.,
    Product Code
    NXC
    PMA / PMN Number
    K981095
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD AND CONCLUSIONS. THE ALIGNERS HAVE BEEN RECEIVED BY ALIGN TECHNOLOGY INC ON 9/28/2010. THE REASON THEY ARE NOT BEING EVALUATED IS BECAUSE IT IS KNOWN THAT ON RARE OCCASION, ALIGNERS MAY CAUSE ALLERGIC REACTION PATIENTS. THIS CAUTION IS ALSO LISTED IN THE INSTRUCTIONS FOR USE PROVIDED WITH THE DEVICE. IN THIS CASE, THE PATIENT PRESENTED WITH SYMPTOMS OF A POSSIBLE ALLERGICA REACTION AFTER ALIGNER USE. THE PATIENT HAS A KNOWN HISTORY OF ANAPHYLAXIS AND ALLERGIC REACTION LEADING TO PREDISPOSITION.

    Description of Event or Problem · 1

    THE TREATING DOCTOR CALLED AND REPORTED THIS EVENT OF A POSSIBLE ALLERGIC REACTION TO ALIGN ON (B)(6) 2010. PATIENT WITH DOCUMENTED HISTORY OF ANAPHYLAXIS STARTED USING INVISALIGN SYSTEM FOR TREATMENT OF MALOCCLUSION ON (B)(6) 2010 AND WITHIN 24-48 HOURS ((B)(6) 2010) NOTICED IRRITATION TO HER CHEEKS AND TONGUE. THE DOCTOR PRESCRIBED BENADRYL WHICH SEEMED TO ALLEVIATE THE SYMPTOMS. AFTER SOME TIME, THE PATIENT RE-TRIED THE ALIGNERS AGAIN AND BEGAN TO FEEL DISTRESSED DUE TO A COMPROMISED AIRWAY. THE PATIENT STOPPED THE USE OF ALIGNERS ON (B)(6) 2010 AND CONTINUE USING THE PRESCRIBED BENADRYL. THIS TREATMENT HELPED WITH THE PATIENT'S IMPROVEMENT. AFTER A FEW DAYS OF NOT WEARING ALIGNERS, THE PATIENT IS SIGNIFICANTLY BETTER. AT PRESENT, THE PATIENT IS FINE PER THE TREATING DOCTOR WHO SAW HER ON (B)(6) 2010 AND HAS DISCONTINUED ALL TREATMENT. THE DOCTOR REPORTED THE EVENT TO ALIGN TECHNOLOGY INC ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVISALIGN SYSTEM SEQUENTIAL ALIGNERS- ORTHODONTIC DEVICE NXC ALIGN TECHNOLOGY INC., FULL 73261658

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention