BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEARCORRECT SYSTEM

    MDR report key: 10610262 · Received September 30, 2020

    Report

    Report Number
    3007130440-2020-00002
    Event Type
    Injury
    Date Received
    September 30, 2020
    Date of Event
    September 4, 2020
    Report Date
    September 30, 2020
    Manufacturer
    CLEARCORRECT LLC
    Product Code
    NXC
    UDI-DI
    D865REF00011
    PMA / PMN Number
    K113618
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: THE CUSTOMER SENT IN SCREENSHOTS OF A TEXT CONVERSATION WITH THE PATIENT. PATIENT STATES AFTER OPENING STEP 5 AND WEARING IT HER LIPS, TONGUE, AND INSIDE OF HER MOUTH SWELLED UP. PATIENT WENT TO URGENT CARE WHERE SHE WAS GIVEN AN EPIPEN AND OTHER MEDICATIONS FOR THE REACTION. A REVIEW OF BATCH 253799 WAS PERFORMED WHERE IT WAS CONFIRMED THERE WERE NO SIMILAR COMPLAINTS, THUS THE EVENT WAS ISOLATED TO THIS CASE. CLINICAL EVALUATION: AN ALLERGIC REACTION CAN BE A MODERATE MEDICAL RISK TO THE PATIENT. REGULATORY EVALUATION: THIS EVENT OCCURRED AT THE START OF TREATMENT STEP 5; THE ACCOUNT DID NOT INDICATE IF THE PATIENT EXHIBITED ANY SIGNS OF ALLERGIC REACTION DURING STEPS 1 TO 4. WHILE THE COMPLAINT IMPLIES AN ALLERGIC REACTION, IT IS NOT CERTAIN THAT IT IS ASSOCIATED WITH THE DEVICE. BECAUSE THE EVENT DID NOT OCCUR UNTIL STEP 5, IT IS NOT AN ACUTE REACTION THAT WOULD REQUIRE MEDICAL INTERVENTION TO AVOID PERMANENT HARM OR DEATH. THE PATIENT DID SEEK MEDICAL TREATMENT AND WAS PRESCRIBED AN EPIPEN. IT IS NOT CLEAR WHETHER THE EPIPEN OR SOME OTHER INTERVENTION WAS AT THE TIME THE PATIENT SOUGHT TREATMENT. BECAUSE IT APPEARS THAT MEDICAL INTERVENTION WAS PERFORMED IN THIS EVENT, THIS EVENT MEETS THE CRITERIA FOR ADVERSE EVENT REPORTING.

    Description of Event or Problem · 1

    THE PATIENT'S LIPS, TONGUE, AND MOUTH SWELLED UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1074108 CLEARCORRECT SYSTEM CLEAR PLASTIC ORTHODONTIC ALIGNER NXC CLEARCORRECT LLC Aligner (Single-Layer) 253799 D865REF00011

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention