BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEAL CLEAR ALIGNERS

    MDR report key: 19168718 · Received April 23, 2024

    Report

    Report Number
    2081322-2024-00001
    Event Type
    Injury
    Date Received
    April 23, 2024
    Date of Event
    April 3, 2024
    Report Date
    April 23, 2024
    Manufacturer
    ORTHO ORGANIZERS, INC.
    Product Code
    NXC
    UDI-DI
    00190707096946
    PMA / PMN Number
    K210613
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER COMPLAINT FORM AND PATIENT QUESTIONNAIRE REGARDING THE REVEAL CLEAR ALIGNERS STANDARD STATE THAT THE 77-YEAR-OLD FEMALE PATIENT PRESENTED WITH AN ALLERGIC REACTION. THE PATIENT STOPPED WEARING THE ALIGNER TRAYS THREE SEPARATE TIMES WITH SEVERAL DAYS IN BETWEEN AND RINSING THE ALIGNERS WITH DAWN SOAP AS ADVISED BY THE DENTAL OFFICE, BUT COULD NOT TOLERATE THE ALIGNERS DUE TO REDNESS OF THE ORAL TISSUE, SWELLING OF THE TONGUE, DIFFICULTY BREATHING, AND TENDER CHAPPED LIPS. AS STATED IN THE PATIENT QUESTIONNAIRE, NO HOSPITAL VISIT WAS INDICATED, AND NO DOCTOR REFERRAL, FOLLOW-UP OR PRESCRIPTION MEDICATIONS WERE REQUIRED. THE PATIENT STOPPED WEARING THE TRAYS, TOOK OTC BENADRYL, AND HAS FULLY RECOVERED. ORTHO ORGANIZERS DECIDED TO REPORT THIS COMPLAINT TO THE FDA BECAUSE THE PATIENT TOOK OTC MEDICATION (BENADRYL).

    Description of Event or Problem · 0

    THE 77-YEAR-OLD FEMALE ALIGNER PATIENT PRESENTED WITH AN ALLERGIC REACTION. THE PATIENT STOPPED WEARING THE ALIGNER TRAYS THREE SEPARATE TIMES WITH SEVERAL DAYS IN BETWEEN AND RINSING THE ALIGNERS WITH DAWN SOAP AS ADVISED BY THE DENTAL OFFICE, BUT COULD NOT TOLERATE THE ALIGNERS DUE TO REDNESS OF THE ORAL TISSUE, SWELLING OF THE TONGUE, DIFFICULTY BREATHING, AND TENDER CHAPPED LIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948180 REVEAL CLEAR ALIGNERS SEQUENTIAL ALIGNERS NXC ORTHO ORGANIZERS, INC. 140-8735 00190707096946

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention