uLab Systems Dental Aligner FG0094 (UDI 00860002380094)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00860002380094), received between Oct 27, 2023 and Mar 18, 2026 — classified as 12 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (12 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2026Patient Device Interaction Problem

  WHO: THE DOCTOR CONTACTED ULAB REGARDING A POSSIBLE ALLERGIC REACTION. NO PHOTOS PROVIDED. WHAT: DR. (B)(6) EMAILED, "PATIENT (B)(6) RESENTED TO CLINIC WITH ALLERGIC REACTION AFTER WEARING ALIGNER #1. PATIENT HAD A HISTORY OF INVISALIGN TIMES 2 WITHOUT ANY PROBLEMS. ARE THE ALIGNERS WASHED BEFORE PACKAGING? WHEN: (B)(6) 2026. WHERE: ALIGNERS WERE IN THE PATIENT'S POSSESSION AT THE TIME OF THE POSSIBLE ALLERGIC REACTION. WHY: NO RMA. NO MANUFACTURING DEFECTS. INSPECTED AT (B)(4) BY #241 ON (B)(6) 2025. PER DISCUSSION IN THE COMPLAINT MEETING ON (B)(6) 2026, WAITING FOR ADDITIONAL INFORMATION. CONCLUSION: THIS COMPLAINT WILL CLOSE AS UNDETERMINED. 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. THE CAUSE OF THE POSSIBLE ALLERGIC REACTION IS UNDETERMINED. THE DOCTOR PROVIDED NO FURTHER INFORMATION. THE PRODUCT WAS NOT RETURNED. ULAB SYSTEMS REPORTED THIS MINOR ALLERGIC REACTION AS AN EMDR THROUGH OUR WEBTRADER PRODUCTION ACCOUNT, ON (B)(6) 2026.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 24627493 ↗
• InjuryJul 29, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  WHO: THE DOCTOR CONTACTED ULAB REGARDING A POSSIBLE ALLERGIC REACTION. WHAT: THE PATIENT IS EXPERIENCING IRRITATION AND IS CURRENTLY UNDER MEDICAL CARE. WHEN: ON (B)(6) 2025. WHERE: AT THE DOCTOR'S OFFICE WHILE TREATING THE PATIENT. WHY: NO RMA NO MANUFACTURING DEFECTS. INSPECTED AT QA03 BY #: (B)(4) ON 1/29/2025 PER DISCUSSION IN THE COMPLAINT MEETING ON (B)(6) 2025, REQUESTING MORE INFORMATION FROM THE DOCTOR REGARDING KNOWN ALLERGIES, DID THE SYMPTOMS STOP ONCE THEY DISCONTINUED WEARING THE ALIGNERS, WHAT WERE THE RESULTS OF THE MEDICAL ATTENTION? CONCLUSION: THIS COMPLAINT WILL CLOSE AS UNDETERMINED. 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. THE CAUSE OF THE POSSIBLE ALLERGIC REACTION IS UNDETERMINED. THE DOCTOR PROVIDED THE SYMPTOMS THE PATIENT DISPLAYED BUT NO FURTHER INFORMATION. THE PRODUCT WAS NOT RETURNED. ULAB SYSTEMS REPORTED THIS MINOR ALLERGIC REACTION AS AN EMDR THROUGH OUR WEBTRADER PRODUCTION ACCOUNT, ON (B)(6) 2025.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22647703 ↗
• InjuryJul 29, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  WHO: THE DOCTOR CONTACTED ULAB REGARDING A POSSIBLE ALLERGY TO REVA MATERIAL. WHAT: PATIENT EXPERIENCED LIP AND THROAT SWELLING. WHEN: (B)(6) 2025. WHERE: ALIGNERS WERE IN THE PATIENT'S POSSESSION. WHY: NO RMA SIX PIECES (L11B, U01B, U02B, U04B, U06B, U11B) REJECTED FOR MISALIGNED TRIM ON (B)(6) 2025. INSPECTED AT QA03 BY #195 ON 5/29/2025. PER DISCUSSION IN THE COMPLAINT MEETING ON (B)(6) 2025, REQUESTING MORE INFORMATION FROM THE DOCTOR REGARDING KNOWN ALLERGIES, DID THE SYMPTOMS STOP ONCE THEY DISCONTINUED WEARING THE ALIGNERS, IS THE PATIENT SEEKING MEDICAL ATTENTION? CONCLUSION: THIS COMPLAINT WILL CLOSE AS UNDETERMINED. 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. THE CAUSE OF THE POSSIBLE ALLERGIC REACTION IS UNDETERMINED. THE DOCTOR PROVIDED THE SYMPTOMS THE PATIENT DISPLAYED BUT NO FURTHER INFORMATION. THE PRODUCT WAS NOT RETURNED. ULAB SYSTEMS REPORTED THIS MINOR ALLERGIC REACTION AS AN EMDR THROUGH OUR WEBTRADER PRODUCTION ACCOUNT, ON (B)(6) 2025.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22647403 ↗
• InjuryJul 23, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  WHO: THE DOCTOR CONTACTED ULAB REGARDING A POSSIBLE ALLERGIC REACTION. WHAT: PATIENT EXPERIENCED HEADACHE AND NAUSEA ALONG WITH SINUS ISSUES. WHEN: (B)(6) 2025. WHERE: ALIGNERS WERE IN THE PATIENT'S POSSESSION AT THE TIME OF THE POSSIBLE ALLERGIC REACTION. WHY: NO RMA. NO MANUFACTURING DEFECTS. INSPECTED AT QA03 ON 5/16/2025 BY #241. PER DISCUSSION IN THE COMPLAINT MEETING ON 6/24/2025, REQUESTING MORE INFORMATION FROM THE DOCTOR REGARDING KNOWN ALLERGIES, DID THEY SEEK MEDICAL ATTENTION, DID THE SYMPTOMS STOP ONCE THEY DISCONTINUED WEARING THE ALIGNERS? PER OFFICE: CAN'T BREATHE AND FACE AND LIPS SWOLLEN. NO KNOWN ALLERGIES. NO ALLERGY TEST PLANNED. TRY A DIFFERENT ALIGNER COMPANY OR PUT HIM IN BRACES. HAD RESTORATIVE WORK. HE WANTS TO SWITCH TO INVISALIGN FROM ANOTHER PROVIDER. WEARING PART TIME. MAYBE STOPPED OVER THE WEEKEND. TRY A DIFFERENT MATERIAL. CONCLUSION: THIS COMPLAINT WILL CLOSE AS UNDETERMINED. 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. THE CAUSE OF THE POSSIBLE ALLERGIC REACTION IS UN

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22575236 ↗
• InjuryMar 13, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  WHO: THE DOCTOR CONTACTED ULAB REGARDING THE POSSIBLE ALLERGIC REACTION. WHAT: OFFICE CALLED AND SAID THEIR PATIENT WAS GIVEN THEIR ALIGNERS THIS MONTH AND IS REPORTING SWELLING AND IRRITATION OF THE TONGUE AND THROAT. WHEN: (B)(6) 2025. WHERE: ALIGNERS WERE IN THE PATIENT'S POSSESSION AT THE TIME OF THE POSSIBLE ALLERGIC REACTION. THE OFFICE ASKED IF WE COULD SEND THE MSDS FOR THE MATERIAL. WHY; NO RMA. ONE PIECE WAS REJECTED FOR A HOLE ON (B)(6) 2024. FINAL QA03 INSPECTION DONE BY #195 ON (B)(6) 2024. PER DISCUSSION IN THE COMPLAINT MEETING ON 3/4/2025, REQUESTED MORE INFORMATION FROM THE DOCTOR, SUCH AS KNOWN ALLERGIES, DID THE PATIENT SEEK MEDICAL ATTENTION, DID THE SYMPTOMS STOP ONCE THEY DISCONTINUED USE OF THE ALIGNERS? NO RESPONSE FROM THE DOCTOR. CONCLUSION: AS WE DID NOT RECEIVE FURTHER INFORMATION, THIS REACTION MAY BE DUE TO OTHER EXTERNAL FACTORS/COMMON ALLERGENS THAT WERE INTRODUCED COINCIDENTALLY AT THE SAME TIME AS THE PLACEMENT OF THE ALIGNERS, SUCH AS POLLENS, DUSTMITES, PET ALLERGENS, BIOLOGIC PRODUCTS, INSECT VENOMS. THE CAUSE OF THE POSSIBLE ALLERGIC REACTION IS UNDETERMINED. THE DOCTOR PROVIDED THE SYMPTOMS THE PATIENT DISPLAYED BUT NO FURTHER INFORMATION. THE

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21595521 ↗
• InjuryNov 20, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  WHO: THE DOCTOR CONTACTED ULAB REGARDING THE BURNING AND FIT/TRIM ISSUE. PHOTOS PROVIDED. REVA MATERIAL. WHAT: SO THE LOWER ALIGNER LOOKED FINE WHEN I TOOK IT OUT OF THE BAG, BUT ONCE IT IS INSERTED, IT RAISES UP/OUT AT LL2. SHE CAME IN WITH A LARGE BALL OF WAX (SEE PHOTOS). I TRIMMED THE TRAY TO SEE IF THAT WOULD HELP. SHE'S COMING BACK IN TODAY TO LET ME KNOW. I TOLD HER I WOULD LOOK INTO THE "BURNING" ASPECT WITH YOU GUYS. BUT SHE'S GOING ON AMAZON AND BUYING WAX IN BULK. WHEN: ON (B)(6) 2024. WHERE: NO RMA TWO PIECES (U14B, U23B) REJECTED BY #: (B)(6) ON 9/4/2024 FOR CRACKS. FINAL QA03 INSPECTION DONE BY #: (B)(6) ON 9/4/2024. PER REVIEW OF THE PHOTOS AND DISCUSSION IN THE COMPLAINT MEETING ON 11/14/2024, POSSIBLE ALLERGIC REACTION. CS TO GET MORE INFORMATION REGARDING OTHER ALLERGIES. CONCLUSION: THE CAUSE OF THE POSSIBLE ALLERGIC REACTION IS UNDETERMINED. THE DOCTOR PROVIDED THE SYMPTOMS THE PATIENT DISPLAYED AND THAT THE PATIENT HAD NO KNOWN ALLERGIES. THE PRODUCT WAS NOT RETURNED. ULAB SYSTEMS REPORTED THIS MINOR ALLERGIC REACTION AS AN EMDR THROUGH OUR WEBTRADER PRODUCTION ACCOUNT, ON 11/20/2024.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 20737394 ↗
• InjuryNov 20, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  WHO: THE DOCTOR CONTACTED ULAB REGARDING A POSSIBLE ALLERGIC REACTION. WHAT: "I SAW A PATIENT TODAY BECAUSE HIS GUMS WERE IRRITATED FROM THE ALIGNERS. HE SAID HE DIDN'T HAVE ANY ISSUES WITH ALIGNER #1, BUT NOW HE IS HAVING ISSUES WITH ALIGNER #2. IT IS MAINLY THE UPPER 1ST & 2ND MOLAR AREA ON THE INSIDE AND OUTSIDE GINGIVAL AREA. THE LOWER GUMS AT THE LOWER 1ST MOLARS WERE SLIGHTLY IRRITATED AS WELL. I POLISHED THE GINGIVAL AREA AND PAPILLA AREA, SO HOPEFULLY THAT WILL HELP. HOWEVER, THE STRANGE PART IS THE ALIGNERS DON'T REALLY TOUCH THE GUMS EXCEPT FOR THE PAPILLA AREA. THAT IS WHY I DON'T KNOW IF THE POLISHING WILL DO ANYTHING. I STARTED TO THINK HE COULD BE HAVING AN ALLERGIC REACTION, BUT IT SHOULD HAVE HAPPENED WITH ALIGNER #1. HOWEVER, ALLERGIC REACTIONS TEND TO GET WORSE OVER TIME LIKE HE COULD HAVE HAD SLIGHT IRRITATION WITH ALIGNER #1, BUT NOW IT HAS GOTTEN WORSE WITH ALIGNER #2 ENOUGH TO REALLY NOTICE IT." WHEN: (B)(6) 2024 WHERE: CHAIRSIDE WHILE DELIVERING THE ALIGNERS TO THE PATIENT. WHY: NO RMA NO MANUFACTURING DEFECTS. INSPECTED AT QA03 BY #241 ON (B)(6) 2024. PER DISCUSSION IN THE COMPLAINT MEETING ON (B)(6) 2024, THE CAUSE OF THE PATIENT'S REACTION REMAINS UNDETERM

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 20735477 ↗
• InjuryMay 22, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  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

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 19371993 ↗
• InjuryMay 21, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  WHAT: DR. (B)(6) WANTED TO KNOW WHAT IS USED TO CLEAN ALIGNERS AFTER MANUFACTURING THEM. PATIENT POSSIBLY HAVING AN ALLERGIC REACTION TO CLEANER. WHEN: (B)(6) 2024. WHERE: CHAIRSIDE WHILE DELIVERING THE ALIGNERS TO THE PATIENT. WHY: NO RMA ISSUED NO MANUFACTURING DEFECTS EMAILED DR. (B)(6) THE SDS ON LIQUINOX. WAITING ON FURTHER INFORMATION AFTER HE RECEIVES EMAIL AND SPEAKS MORE WITH PATIENT. 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. UPON REQUEST FOR FURTHER INFORMATION, THE DOCTOR RESPONDED THAT AFTER CLEANING THE PARTS WITH ANTI-BACTERIAL SOAP AND MOUTHWASH, THE PATIENT HAD NO FURTHER ISSUES

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 19366879 ↗
• InjuryMay 8, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  WHO: THE DOCTOR CONTACTED ULAB REGARDING A POSSIBLE ALLERGIC REACTION TO ALIGNERS. WHAT: THE PATIENT EXPERIENCED A POSSIBLE ALLERGIC REACTION TO ALIGNERS AFTER FEW WEEKS OF USE. WHEN: 4/12/2024 WHERE: THE ALIGNERS WERE IN THE PATIENT'S POSSESSION AT THE TIME OF THE ALLERGIC REACTION. WHY: THE PATIENT HAD A PRIOR POSSIBLE ALLERGIC REACTION TO PREVIOUS ALIGNERS (JRN10). THERE HAS BEEN NO ADDITIONAL INFORMATION REGARDING THE PATIENT'S ALLERGY HISTORY, ETC, PROVIDED BY THE DOCTOR. NO RMA ISSUED. THERE WAS NO MANUFACTURING DEFECTS DETECTED. THE CAUSE OF THE PATIENT'S REACTION REMAINS UNDETERMINED. IT IS NOT KNOWN IF THE ALIGNER 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 INTRODUCTED COINCIDENTALLY AT THE TIME OF THE PLACEMENT OF THE ALIGNERS, SUCH AS POLLENS, DUST MITES, 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 WEB TRADER PRODUCTION A

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 19274317 ↗
• InjuryNov 28, 2023Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  WHO: THE DOCTORS OFFICE INFORMED ULAB OF A PATIENT WITH A POSSIBLE ALLERGIC REACTION. WHAT: PATIENT HAD A POSSIBLE ALLERGIC REACTION TO ALIGNER # 4 WITH HIS ULAB TREATMENT. WHEN: (B)(6) 2023. WHERE: THIS ISSUE OCCURRED WHILE THE PATIENT WAS WEARING ALIGNER #4 (PERSONAL LIFESTYLE) AFTER BEING FIT IN THE DOCTOR'S OFFICE. WHY: NO RMA ISSUED. AS OF 11/28/23, THERE HAS BEEN NO ADDITIONAL INFORMATION REGARDING THE PATIENT'S ALLERGY HISTORY, ETC, PROVIDED BY THE DOCTOR. IT IS UNDETERMINED AS TO WHY THE PATIENT WAS REACTIVE TO THE STAGE 4 ALIGNERS, BUT NOT THE PREVIOUS 1-3 STAGE ALIGNERS, AS THEY ARE ALL MADE OF THE SAME ZENDURA MATERIAL AND PROCESSED TOGETHER THROUGH THE MANUFACTURING PROCESS. 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 STAGE 4 ALIGNERS, SUCH AS POLLENS, DUSTMITES, PET ALLERGENS, BIOLOGIC PRODUCTS, INSECT VENOMS, OR OTHER ORTHODONTIC TREATMENT MATERIALS INCLUDING GLUES/ADHESIVES, RUBBER BANDS, LATEX, OR ATTACHMENT MATERIALS USED IN THE TREATMENT PLANNING. IT IS UNDETERMINED IF THE ZENDURA FLX MATERIAL WAS THE C

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18220385 ↗
• InjuryOct 27, 2023Device Appears to Trigger Rejection; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Biocompatibility; Patient Device Interaction Problem; Device Appears to Trigger Rejection; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Biocompatibility; Patient Device Interaction Problem

  ON (B)(6) 2023, THE DOCTORS OFFICE INFORMED ULAB SYSTEMS' CLIENT SERVICES GROUP THAT THEIR PATIENT HAD A POTENTIAL ALLERGIC REACTION DURING THEIR TREATMENT TO A USMILE ALIGNER. WHY: NO RMA ISSUED. CLIENT SERVICES REPLIED VIA EMAIL TO THE DOCTOR'S OFFICE AND PROVIDED THE MSDS SHEET FOR THE ALIGNER MATERIAL WHICH IS USED TO MANUFACTURER THE USMILE ALIGNERS. CLIENT SERVICES ALSO ASKED THE DOCTOR IF THE PATIENT HAD ANY KNOWN ALLERGIES, AND THE DOCTOR RESPONDED THAT THE PATIENT IS ALLERGIC TO SULFA DRUGS (CO-TRIMOXAZOLE (SEPTRIN), SULFADIAZINE, SULFAMETHOXAZOLE (GANTANOL), TRIMETHOPRIM-SULFAMETHOXAZOLE (BACTRIM, BACTRIM DS, SEPTRA, AND SEPTRA DS), TRIMETHOPRIM (TRIMPEX, PROLOPRIM, AND PRIMSOL), SULFASALAZINE (AZULFIDINE EN-TABS, AZULFIDINE, AND SULFAZINE), SULFISOXAZOLE (GANTRISIN)) WHICH ARE COMMONLY USED TO TREAT BACTERIAL INFECTIONS. THE DOCTOR STATED THAT THE PATIENT HAD A REACTION WITH 2 ALIGNERS IN THE 1ST REFINEMENT AND 1 ALIGNER IN THE 2ND REFINEMENT, WHICH RESULTED IN SWELLING FOR ABOUT 3-4 WEEKS. THE DOCTOR ALSO STATED "I'M NOT SURE IT WAS AN ALLERGY, BECAUSE IT WAS ONLY 1 ALIGNER. I HAD AN INVISALIGN PATIENT THAT HAD A POLYESTER ALLERGY, THAT COULD NOT TOLERATE ANY ALIGNERS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18023101 ↗