BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVISALIGN SYSTEM

    MDR report key: 2249686 · Received August 25, 2011

    Report

    Report Number
    2953749-2011-00108
    Event Type
    Other
    Date Received
    August 25, 2011
    Date of Event
    May 1, 2011
    Report Date
    August 17, 2011
    Manufacturer
    ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    PMA / PMN Number
    K081960
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALIGNERS ARE NOT BEING EVALUATED (METHOD) AS THE PRODUCT PERFORMED IN ACCORDANCE TO SPECIFICATIONS (RESULTS, CONCLUSION) AND THE DEVICE WAS USED IN ACCORDANCE WITH LABELED INDICATIONS (RESULTS). THE REPORTED SYMPTOMS OF A SWOLLEN PALATE, SWOLLEN LYMPH NODES, DIFFICULTY IN BREATHING, GASTRITIS AND PNEUMONIA ARE OF A CONCERN AND ARE POTENTIALLY SERIOUS IN NATURE. NO CONCLUSIVE EVIDENCE HAS BEEN PROVIDED THAT SUPPORTS OR OPPOSES THE FACT THAT THE INVISALIGN PRODUCT CAUSE OR CONTRIBUTED TO THE PT SYMPTOMS. SINCE THE PT REPORTED BEING HOSPITALIZED FOR APPROXIMATELY 10 DAYS DUE TO THE REPORTED SYMPTOMS, AND THE TREATING DOCTOR BELIEVES THE EVENT MAY HAVE BEEN SERIOUS IN NATURE A MDR IS BEING FILED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, DR (B)(6) CALLED DR. (B)(6), WHO REPORTED THE PT STARTED TREATMENT AROUND (B)(6) 2011. DOCTOR DELIVERED ALIGNERS 1, 2 AND 3, AND THE PT WAS ABLE TO TOLERATE THEM, BUT AROUND ALIGNER STAGE #4, THE REPORTED SYMPTOMS OF A SWOLLEN PALATE, SWOLLEN LYMPH NODES, DIFFICULTY IN BREATHING, GASTRITIS AND PNEUMONIA. THE PT REPORTED THAT SHE WAS HOSPITALIZED FOR APPROXIMATELY 10 DAYS DUE TO THESE SYMPTOMS. A PHYSICIAN IN THE HOSPITAL INDICATED THAT THESE SYMPTOMS MAY HAVE BEEN CAUSED BY THE ALIGNERS, BUT NO MEDICAL REPORT WAS PROVIDED. CURRENTLY THE PT HAS STOPPED TREATMENT AND IS DOING WELL, AND IS ASYMPTOMATIC. THE TREATING DOCTOR BELIEVES THE EVENT MAY HAVE BEEN SERIOUS IN NATURE CONSIDERING THE FACT SHE WAS HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVISALIGN SYSTEM SEQUENTIAL ALIGNERS - ORTHODONTIC DEVICE NXC ALIGN TECHNOLOGY, INC. INVISALIGN FULL 82632852

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR