BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULAB SYSTEMS DENTAL ALIGNER

    MDR report key: 19371993 · Received May 22, 2024

    Report

    Report Number
    3017155477-2024-00011
    Event Type
    Injury
    Date Received
    May 22, 2024
    Date of Event
    May 1, 2024
    Report Date
    May 22, 2024
    Manufacturer
    ULAB SYSTEMS
    Product Code
    NXC
    UDI-DI
    00860002380094
    PMA / PMN Number
    K192596
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WHO: THE DOCTOR CONTACTED ULAB REGARDING A POSSIBLE ALLERGIC REACTION. WHAT: PATIENT WORE THE ALIGNERS, TRACKING, EVERYTHING WAS FINE. WHEN IT WAS TIME TO WEAR TRAY #8 (UPPER AND LOWER), THE PATIENT BROKE OUT IN RASHES ALL OVER HER BODY. THE DOCTOR ADVISED THE PATIENT TO GO BACK TO TRAYS #7 TO PINPOINT IF TRAYS #8 WAS THE ISSUE, THE PATIENT'S RASHES CLEARED UP. THEY THEN THOUGHT IT WAS A FLUKE DEAL, HAD THE PATIENTS PROGRESS TO TRAYS #8 (UPPER AND LOWER), SHE BROKE OUT IN RASHES AGAIN. THE PATIENT HAS SKIPPED TO ALIGNER #9 AND THEY ARE WAITING TO SEE IF SHE HAS A REACTION. · IF SHE DOES HAVE A REACTION, I WOULD LIKE TO OFFER TO REMAKE ALIGNERS 7-11 UPPER 7-13 LOWER. · I ASKED IF THEY HAD #8 TO SHIP BACK TO US FOR INVESTIGATION BUT THE DOCTOR DOES NOT HAVE IT AT THIS TIME. THE ALIGNERS ARE WITH THE PATIENT. · (B)(6) SENT ME THE MSDS SHEETS, AND I WILL SEND THOSE TO DR. (B)(6) AND HIS TEAM. WHEN: (B)(6) 2024. WHERE: ALIGNERS WERE IN THE PATIENT'S POSSESSION AT THE TIME OF THE POSSIBLE ALLERGIC REACTION. AS OF (B)(6) 2024, THERE HAS BEEN NO ADDITIONAL INFORMATION REGARDING THE PATIENT'S ALLERGY HISTORY, ETC, PROVIDED BY THE DOCTOR. WHY: NO RMA NO MANUFACTURING DEFECTS. PER DISCUSSION IN THE COMPLAINT MEETING ON 5/2/2024, THE CAUSE OF THE PATIENT'S REACTION REMAINS UNDETERMINED. IT IS NOT KNOWN IF THE ALIGNER MATERIAL OR OTHER MATERIALS USED DURING THE TREATMENT (ADHESIVES/ATTACHMENT BONDING/LATEX) CAUSED THE PATIENT'S ALLERGIC REACTION. AS WE DON'T HAVE ANY INFORMATION ON THE PATIENT'S ALLERGY HISTORY, THIS REACTION MAY BE DUE TO OTHER EXTERNAL FACTORS/COMMON ALLERGENS THAT WERE INTRODUCED COINCIDENTALLY AT SAME TIME AS THE PLACEMENT OF THE ALIGNERS, SUCH AS POLLENS, DUSTMITES, PET ALLERGENS, BIOLOGIC PRODUCTS, INSECT VENOMS. CONCLUSION: THE CAUSE OF THE POSSIBLE ALLERGIC REACTION IS UNDETERMINED. ULAB SYSTEMS REPORTED THIS MINOR ALLERGIC REACTION AS AN EMDR THROUGH OUR WEBTRADER PRODUCTION ACCOUNT, ON 05/22/2024.

    Description of Event or Problem · 0

    WHO: THE DOCTOR CONTACTED ULAB REGARDING A POSSIBLE ALLERGIC REACTION. WHAT: PATIENT WORE THE ALIGNERS, TRACKING, EVERYTHING WAS FINE. WHEN IT WAS TIME TO WEAR TRAY #8 (UPPER AND LOWER), THE PATIENT BROKE OUT IN RASHES ALL OVER HER BODY. THE DOCTOR ADVISED THE PATIENT TO GO BACK TO TRAYS #7 TO PINPOINT IF TRAYS #8 WAS THE ISSUE, THE PATIENT'S RASHES CLEARED UP. THEY THEN THOUGHT IT WAS A FLUKE DEAL, HAD THE PATIENTS PROGRESS TO TRAYS #8 (UPPER AND LOWER), SHE BROKE OUT IN RASHES AGAIN. THE PATIENT HAS SKIPPED TO ALIGNER #9 AND THEY ARE WAITING TO SEE IF SHE HAS A REACTION. · IF SHE DOES HAVE A REACTION, I WOULD LIKE TO OFFER TO REMAKE ALIGNERS 7-11 UPPER 7-13 LOWER · I ASKED IF THEY HAD #8 TO SHIP BACK TO US FOR INVESTIGATION BUT THE DOCTOR DOES NOT HAVE IT AT THIS TIME. THE ALIGNERS ARE WITH THE PATIENT. · (B)(6) SENT ME THE MSDS SHEETS, AND I WILL SEND THOSE TO DR. (B)(6) AND HIS TEAM. WHEN: (B)(6) 2024. WHERE: ALIGNERS WERE IN THE PATIENT'S POSSESSION AT THE TIME OF THE POSSIBLE ALLERGIC REACTION. AS OF (B)(6) 2024, THERE HAS BEEN NO ADDITIONAL INFORMATION REGARDING THE PATIENT'S ALLERGY HISTORY, ETC, PROVIDED BY THE DOCTOR. WHY: NO RMA. NO MANUFACTURING DEFECTS. PER DISCUSSION IN THE COMPLAINT MEETING ON 5/2/2024, THE CAUSE OF THE PATIENT'S REACTION REMAINS UNDETERMINED. IT IS NOT KNOWN IF THE ALIGNER MATERIAL OR OTHER MATERIALS USED DURING THE TREATMENT (ADHESIVES/ATTACHMENT BONDING/LATEX) CAUSED THE PATIENT'S ALLERGIC REACTION. AS WE DON'T HAVE ANY INFORMATION ON THE PATIENT'S ALLERGY HISTORY, THIS REACTION MAY BE DUE TO OTHER EXTERNAL FACTORS/COMMON ALLERGENS THAT WERE INTRODUCED COINCIDENTALLY AT SAME TIME AS THE PLACEMENT OF THE ALIGNERS, SUCH AS POLLENS, DUSTMITES, PET ALLERGENS, BIOLOGIC PRODUCTS, INSECT VENOMS. CONCLUSION: THE CAUSE OF THE POSSIBLE ALLERGIC REACTION IS UNDETERMINED. ULAB SYSTEMS REPORTED THIS MINOR ALLERGIC REACTION AS AN EMDR THROUGH OUR WEBTRADER PRODUCTION ACCOUNT, ON 05/22/2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1768260 ULAB SYSTEMS DENTAL ALIGNER CLEAR ALIGNER NXC ULAB SYSTEMS FG0094 00860002380094

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other FG0094, ULAB SYSTEMS USMILE ALIGNER KIT