BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULAB SYSTEMS DENTAL ALIGNER

    MDR report key: 14456599 · Received May 20, 2022

    Report

    Report Number
    3017155477-2022-00002
    Event Type
    Injury
    Date Received
    May 20, 2022
    Date of Event
    April 22, 2022
    Report Date
    May 12, 2022
    Manufacturer
    ULAB SYSTEMS
    Product Code
    NXC
    PMA / PMN Number
    K192596
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WHO: THE DOCTORS OFFICE CALLED STATING THAT THE PATIENT HAD A MINOR ALLERGIC REACTION DURING THE ALIGNER/ORTHODONTIC TREATMENT. WHAT: THE PATIENT HAD AN ALLERGIC REACTION TO THE ALIGNER OR ATTACHMENT MATERIAL USED FOR TREATMENT. WHEN: (B)(6) 2022. WHERE: THIS WAS NOTICED BY THE DOCTORS OFFICE AS THE PATIENT HAD A MINOR ALLERGIC REACTION DURING TREATMENT. WHY: THE CAUSE OF THE PATIENT'S MINOR ALLERGIC REACTION IS UNDETERMINED. IT IS NOT KNOWN IF THE ALIGNER MATERIAL, ADHESIVES/ATTACHMENT BONDING, OR LATEX CAUSED THE PATIENT'S ALLERGIC REACTION. IT WAS CONFIRMED THAT THE PATIENT IS NOT WEARING ELASTICS AS PART OF THE ORTHODONTIC TREATMENT. CONCLUSION: THE PATIENT HAS STOPPED WEARING THE ALIGNERS AND DISCONTINUED THE ALIGNER TREATMENT. CLIENT SERVICES FOLLOWED UP WITH THE DOCTOR ON (B)(6) 2022 ON THE PATIENT'S CONDITION. PER DOCTOR'S STAFF MEMBER, AN ALLERGY TEST HAS NOT BEEN DONE. THE STAFF MEMBER STATED THAT IT COULD BE A FUNGAL INFECTION AND THAT THEY GAVE THE PATIENT MEDICATION CALLED NYSTATIN CRÈME. THE STAFF MEMBER STATED THAT IT SEEMS TO BE WORKING TO ALLEVIATE THE ALLERGIC REACTION. CLIENT SERVICES FOLLOWED UP WITH THE DOCTOR AGAIN ON (B)(6) 2022 ON THE PATIENT'S CONDITION. PER DOCTOR, "SHE STOPPED WEARING THE TRAYS AND EVERYTHING CLEARED UP. WE REFUNDED HER AND SHE IS FINE. IF ANYTHING CHANGES I WILL LET Y.

    Description of Event or Problem · 0

    ON (B)(6) 2022, ULAB CLIENT SERVICES WAS NOTIFIED OF A PATIENT WITH A POTENTIAL ALLERGIC REACTION TO THE USMILE ALIGNER WHICH IS MANUFACTURED USING THE ZENDURA FLX MATERIAL. THE FEEDBACK WAS DOCUMENTED IN THE DOT COMPLIANCE EQMS AS A PRODUCT COMPLAINT (B)(4), PER SOP0013, COMPLAINT HANDLING. THE SOURCE OF THE POTENTIAL ALLERGIC REACTION AND SEVERITY FOR THE PATIENT ARE UNKNOWN. IT IS NOT KNOWN IF THE ALIGNER MATERIAL, ADHESIVES/ATTACHMENT BONDING, RUBBER BANDS, OR LATEX CAUSED THE PATIENT'S ALLERGIC REACTION. IT WAS CONFIRMED THAT THE PATIENT IS NOT WEARING ELASTICS AS PART OF THE ORTHODONTIC TREATMENT. THE DOCTOR STATED "HE IS NOT CERTAIN ISSUE IS CAUSED BY OUR ALIGNERS. HE THOUGHT IT COULD BE A FUNGUS (AND GAVE HER ANTI-FUNGUS CREAM, BUT DIDN'T SEEM TO HELP) OR COULD BE A VIRUS (WHICH SHE IS BEING TREATED FOR BY MEDICAL DOCTOR.)". ULAB SYSTEMS CLIENT SERVICES FOLLOWED UP WITH THE DOCTOR ON 4.26.22 TO CHECK ON THE PATIENT'S CONDITION. PER THE DOCTOR'S STAFF MEMBER, AN ALLERGY TEST HAS NOT BEEN CONDUCTED AND THERE WERE NO FUTURE PLANS FOR AN ALLERGY TEST TO BE CONDUCTED ON THE PATIENT. THE STAFF MEMBER STATED THAT IT COULD BE A FUNGAL INFECTION AND THAT THEY GAVE THE PATIENT MEDICATION CALLED NYSTATIN CRÈME, WHICH SEEMED TO BE WORKING TO ALLEVIATE THE ALLERGIC REACTION. ULAB CLIENT SERVICES FOLLOWED UP WITH THE DOCTOR'S OFFICE AGAIN ON (B)(6) 2022 AND PER THE DOCTOR, "SHE STOPPED WEARING THE TRAYS AND EVERYTHING CLEARED UP. WE REFUNDED HER AND SHE IS FINE. IF ANYTHING CHANGES I WILL LET YOU KNOW." IN CONCLUSION IT IS UNDETERMINED IF THE ZENDURA FLX ALIGNER MATERIAL, ATTACHMENT MATERIALS, GLUES/ADHESIVES, RUBBER BANDS, OR LATEX CAUSED THE PATIENT'S ALLERGIC REACTION. THE PATIENT HAS STOPPED WEARING THE ALIGNERS AND DISCONTINUED THE CLEAR ALIGNER TREATEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523167 ULAB SYSTEMS DENTAL ALIGNER FG0094, ULAB SYSTEMS ALIGNER KIT NXC ULAB SYSTEMS FG0094 OGJ99

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other FG0094, ULAB SYSTEMS USMILE DENTAL ALIGNER KIT