BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMYLIO (ORTHOFX) CLEAR ALIGNERS

    MDR report key: 9713877 · Received February 14, 2020

    Report

    Report Number
    3015143007-2020-00001
    Event Type
    Injury
    Date Received
    February 14, 2020
    Date of Event
    January 16, 2020
    Report Date
    February 11, 2020
    Manufacturer
    SMYLIO
    Product Code
    NXC
    PMA / PMN Number
    K173784
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT REPORTED EVENT AND THEN CALLED AND SAID IT DIDN'T HAPPEN. SMYLIO ASKED FOR THE PRODUCT TO BE RETURNED AND FOR ANY PICTURES OF THE REACTION TO BE TAKEN AND PROVIDED. THE PATIENT DID NOT RESPOND TO THIS REQUEST OR BY THE DDS REQUEST TO COME IN AND BE SEEN. WE WILL ASK FOR RETURN OF THE ALIGNER IF SHE COMES BACK TO THE DENTIST. WE CAN NOT CONFIRM THAT AN ALLERGIC REACTION EVEN TOOK PLACE. HOWEVER, WE DO KNOW FROM OUR RISK ANALYSIS THAT THIS TYPE OF EVENT MAY OCCUR IN RARE PATIENTS. THERE WERE NO ABNORMALITIES IN THE MATERIALS, PRODUCTION, PACKAGING OR SHIPMENT OF THE PRODUCT. SMYLIO CONSIDERS THIS EVENT CLOSED. HOWEVER IF ADDITIONAL INFORMATION IS PROVIDED BY THE PATIENT OR DDS, WE WILL REOPEN THE INVESTIGATION.

    Description of Event or Problem · 1

    THE PATIENT REACHED OUT TO OUR CUSTOMER SERVICE REPRESENTATIVE AND REPORTED THAT SHE WAS HAVING AN ALLERGIC REACTION TO THE ALIGNERS IN THE FORM OF A RASH NEAR HER MOUTH. THE REPRESENTATIVE INFORMED HER THAT SHE SHOULD DISCONTINUE USE AND CONTACT HER PHYSICIAN (DR. (B)(6)). THE PATIENT REQUESTED A MATERIAL/INGREDIENTS LIST AND THE REPRESENTATIVE RESPONDED THAT THEY DIDN'T HAVE THAT INFORMATION AT THIS TIME BUT WOULD WORK TO GET IT TO THEM. A QUALITY REPRESENTATIVE CONTACTED THE OFFICE AND LEARNED THAT THE PATIENT CONTACTED THE OFFICE REPORTING THE ISSUE, STATING THAT SHE WAS HAVING AN ALLERGIC REACTION TO THE ALIGNER AND THE TOOTHPASTE. THE OFFICE SUGGESTED THAT SHE COME IN AND SEE A PHYSICIAN, BUT THE PATIENT WAS UNSURE. THE PATIENT CONTACTED THE CUSTOMER SERVICE REPRESENTATIVE AGAIN ASKING FOR THE MATERIAL LIST, AND THE REPRESENTATIVE INFORMED HER THAT HE WAS WORKING ON GETTING THAT INFORMATION. THE PATIENT CONTACTED THE OFFICE AGAIN TO DISCUSS HER SITUATION AND AGREED TO COME IN FOR AN APPOINTMENT. UPDATE 02/11/2020 : PATIENT REPORTED TO DDS THAT SHE DOES NOT THINK SHE HAD AN ALLERGIC REACTION AND STILL HAS NOT COME IN FOR A FOLLOW UP VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177622 SMYLIO (ORTHOFX) CLEAR ALIGNERS CLEAR ALIGNERS NXC SMYLIO CLEAR ALIGNER N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other