BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULAB SYSTEMS DENTAL ALIGNER

    MDR report key: 14879041 · Received June 30, 2022

    Report

    Report Number
    3017155477-2022-00003
    Event Type
    Injury
    Date Received
    June 30, 2022
    Date of Event
    June 3, 2022
    Report Date
    June 30, 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

    ON 06/03/2022, ULAB SYSTEMS CLIENT SERVICES WAS NOTIFIED OF A PATIENT WITH A POTENTIAL ALLERGIC REACTION TO THE USMILE ALIGNER WHICH IS MANUFACTURED USING THE ZENDURA FLX MATERIAL. THIS FEEDBACK WAS DOCUMENTED IN THE DOT COMPLIANCE EQMS AS A PRODUCT COMPLAINT- (B)(4), PER (B)(4), COMPLAINT HANDLING. THE DOCTOR'S OFFICE REPORTED THAT THEIR PATIENT CALLED TTHE OFFICE AND STATED THAT SHE HAD AN ALLERGIC REACTION WITH SWELLING OF HER TONGUE, AND PALATE ALONG WITH THE GUMS. THE DOCTOR STATED THAT THE PATIENT WAS FIRST IN ALIGNERS THAT WERE MADE IN THE OFFICE AND THEN TRANSITIONED TO THE ULAB USMILE ALIGNERS. THE DOCTOR REQUESTED DOCUMENTATION FROM ULAB CLIENT SERVICES ABOUT POSSIBLE CAUSES OF ALLERGIC REACTIONS? HOW CAN WE FIND OUT MORE? CLIENT SERVICES REPLIED VIA EMAIL EXPLAINING POSSIBLE SOURCES FOR ALLERGIC REACTIONSINCLUDING ELASTICS, ADHESIVE, CLEANER, ECT. ULAB SYSTEMS CLIENT SERVICES FORWARDED AN MSDS SHEET FOR THE ZENDURA FLX MATERIAL WHICH IS USED TO MANUFACTURE THE USMILE ALIGNERS ALONG WITH THE MSDS SHEET FOR THE LIQUINOX SURFECTANT WHICH IS USED TO CLEAN THE ALIGNERS. ADDITIONALLY, CLIENT SERVICES FOLLOWED UP WITH THE DOCTOR'S OFFICE: 1.WHAT IS THE PATIENTS' HEALTH OUTCOME? 2.IS THE ALLERGIC REACTION RESOLVED? 3.DID THE PATIENT NEED MEDICAL ATTENTION LIKE MEDICATIONS OR SOMETHING ELSE TO RESOLVE THE ALLERGIC ISSUE? 4.HE WANTS TO KNOW WHETHER TO REORDER AND SEE IF IT HAPPENS AGAIN OR IF HE SHOULD PRINT IN HOUSE. PLEASE 5.ASK IF THE PATIENT HAS ANY KNOWN ALLERGIES. CLIENT SERVICES REACHED OUT TO THE DOCTOR'S OFFICE ON 6/6/22, BUT DID NOT RECEIVE AN ANSWER. CLIENT SERVICES REACHED OUT TO THE DOCTOR'S OFFICE AGAIN ON 6/7/22 TO SPEAK WITH THE DOCTOR AND LEFT A VOICEMAIL. THE DOCTOR SENT AN EMAIL REPLY TO THE QUESTIONS POSED BY CLIENT SERVICES- DOCTOR EMAIL: "THE PATIENT HAS NO KNOWN ALLERGIES. SHE WAS IN THE ZENDURA ALIGNER MATERIAL FOR THE FIRST 3 THAT WE PRINTED IN THE OFFICE. SHE STARTED HAVING SWELLING OF HER GUMS AND REDNESS ON THE ROOF OF HER MOUTH. AFTER A DAY OR SO SHE TOOK THE ALIGNERS OFF AND ACCORDING TO HER IT TOOK ABOUT 2 MORE DAYS FOR THE REDNESS TO GO AWAY. SHE IS CURRENTLY BACK IN HER IN-OFFICE PRINTED ALIGNER #3. I WILL GET IN TOUCH WITH THE PATIENT ABOUT THE INFORMATION YOU PROVIDED. WE WILL GO AHEAD AND PRINT THE REMAINING ALIGNERS IN MY OFFICE FOR NOW. PLEASE GO AHEAD AND CREDIT MY ACCOUNT FOR HER CASE. THANK YOU FOR YOUR TIME!" DUE TO THIS POTENTIAL ALLERGIC REACTION, THE ORTHODONTIST STOPPED THE PATIENT'S TREATMENT WITH THE ULAB USMILE ALIGNERS AND PLACED THE PATIENT BACK IN THE "IN-OFFICE" PRINTED ALIGNERS. IN CONCLUSION, THE SOURCE OF THE POTENTIAL ALLERGIC REACTION IS UNDETRERMINED AND THE SEVERITY OF THE PATIENT'S ALLERGIC REACTION WAS MILD AS THE REDNESS AND SWELLING OF THE PATIENT'S TONGUE/PALATE/AND GUMS WENT AWAY WITHIN TWO DAYS.

    Description of Event or Problem · 0

    ON (B)(6) 2022 ULAB SYSTEMS CLIENT SERVICES WAS NOTIFIED OF A PATIENT WITH A POTENTIAL ALLERGIC REACTION TO THE USMILE ALIGNER WHICH IS MANUFACTURED USING THE ZENDURA FLX MATERIAL. THIS FEEDBACK WAS DOCUMENTED IN THE DOT COMPLIANCE EQMS AS A PRODUCT COMPLAINT- (B)(4), PER (B)(4), COMPLAINT HANDLING. THE DOCTOR'S OFFICE REPORTED THAT THEIR PATIENT CALLED TTHE OFFICE AND STATED THAT SHE HAD AN ALLERGIC REACTION WITH SWELLING OF HER TONGUE, AND PALATE ALONG WITH THE GUMS. THE DOCTOR STATED THAT THE PATIENT WAS FIRST IN ALIGNERS THAT WERE MADE IN THE OFFICE AND THEN TRANSITIONED TO THE ULAB USMILE ALIGNERS. THE DOCTOR REQUESTED DOCUMENTATION FROM ULAB CLIENT SERVICES ABOUT POSSIBLE CAUSES OF ALLERGIC REACTIONS? HOW CAN WE FIND OUT MORE? CLIENT SERVICES REPLIED VIA EMAIL EXPLAINING POSSIBLE SOURCES FOR ALLERGIC REACTIONSINCLUDING ELASTICS, ADHESIVE, CLEANER, ECT. ULAB SYSTEMS CLIENT SERVICES FORWARDED AN MSDS SHEET FOR THE ZENDURA FLX MATERIAL WHICH IS USED TO MANUFACTURE THE USMILE ALIGNERS ALONG WITH THE MSDS SHEET FOR THE LIQUINOX SURFECTANT WHICH IS USED TO CLEAN THE ALIGNERS. ADDITIONALLY, CLIENT SERVICES FOLLOWED UP WITH THE DOCTOR'S OFFICE: 1.WHAT IS THE PATIENTS' HEALTH OUTCOME? 2.IS THE ALLERGIC REACTION RESOLVED? 3.DID THE PATIENT NEED MEDICAL ATTENTION LIKE MEDICATIONS OR SOMETHING ELSE TO RESOLVE THE ALLERGIC ISSUE? 4.HE WANTS TO KNOW WHETHER TO REORDER AND SEE IF IT HAPPENS AGAIN OR IF HE SHOULD PRINT IN HOUSE. PLEASE 5.ASK IF THE PATIENT HAS ANY KNOWN ALLERGIES. CLIENT SERVICES REACHED OUT TO THE DOCTOR'S OFFICE ON 6/6/22, BUT DID NOT RECEIVE AN ANSWER. CLIENT SERVICES REACHED OUT TO THE DOCTOR'S OFFICE AGAIN ON 6/7/22 TO SPEAK WITH THE DOCTOR AND LEFT A VOICEMAIL. THE DOCTOR SENT AN EMAIL REPLY TO THE QUESTIONS POSED BY CLIENT SERVICES- DOCTOR EMAIL: "THE PATIENT HAS NO KNOWN ALLERGIES. SHE WAS IN THE ZENDURA ALIGNER MATERIAL FOR THE FIRST 3 THAT WE PRINTED IN THE OFFICE. SHE STARTED HAVING SWELLING OF HER GUMS AND REDNESS ON THE ROOF OF HER MOUTH. AFTER A DAY OR SO SHE TOOK THE ALIGNERS OFF AND ACCORDING TO HER IT TOOK ABOUT 2 MORE DAYS FOR THE REDNESS TO GO AWAY. SHE IS CURRENTLY BACK IN HER IN-OFFICE PRINTED ALIGNER #3. I WILL GET IN TOUCH WITH THE PATIENT ABOUT THE INFORMATION YOU PROVIDED. WE WILL GO AHEAD AND PRINT THE REMAINING ALIGNERS IN MY OFFICE FOR NOW. PLEASE GO AHEAD AND CREDIT MY ACCOUNT FOR HER CASE. THANK YOU FOR YOUR TIME!" DUE TO THIS POTENTIAL ALLERGIC REACTION, THE ORTHODONTIST STOPPED THE PATIENT'S TREATMENT WITH THE ULAB USMILE ALIGNERS AND PLACED THE PATIENT BACK IN THE "IN-OFFICE" PRINTED ALIGNERS. IN CONCLUSION, THE SOURCE OF THE POTENTIAL ALLERGIC REACTION IS UNDETRERMINED AND THE SEVERITY OF THE PATIENT'S ALLERGIC REACTION WAS MILD AS THE REDNESS AND SWELLING OF THE PATIENT'S TONGUE/PALATE/AND GUMS WENT AWAY WITHIN TWO DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366248 ULAB SYSTEMS DENTAL ALIGNER FG0094, ULAB SYSTEMS ALIGNER KIT NXC ULAB SYSTEMS FG0094 LGA08

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Prefer Not To Disclose Other FG0094, ULAB SYSTEMS USMILE ALIGNER KIT