ULAB SYSTEMS DENTAL ALIGNER
Report
- Report Number
- 3017155477-2024-00012
- Event Type
- Injury
- Date Received
- June 4, 2024
- Date of Event
- May 30, 2024
- Report Date
- June 4, 2024
- Manufacturer
- ULAB SYSTEMS
- Product Code
- NXC
- PMA / PMN Number
- K192596
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
WHO: THE DOCTOR CONTACTED ULAB REGARDING THE POSSIBLE ALLERGIC REACTION. WHAT: (B)(6) AT THE OFFICE CALLED TO SAY THAT THE PATIENT SEEMED TO HAVE AN ALLERGIC REACTION. WHEN: (B)(6) 2024 WHERE: RETAINERS WERE IN THE PATIENT'S POSSESSION AT THE TIME OF THE POSSIBLE ALLERGIC REACTION. PER DOCTOR, THE PATIENT HAD NO KNOWN ALLERGIES, BUT EXPERIENCED A SWOLLEN TONGUE AND LIPS. ASKED IF THE PATIENT HAD DONE ALIGNER TREATMENT THROUGH ANOTHER COMPANY AND (B)(6) STATED THAT THE PATIENT HAS A BONDED WIRE ON THEIR LOWER ARCH. WHY: NO RMA NO MANUFACTURING DEFECTS. INSPECTED AT QA03 BY #97 ON (B)(6) 2024. PER DISCUSSION IN THE COMPLAINT MEETING ON (B)(6) 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) OR IF MATERIALS USED BY THE OTHER COMPANY WHEN PLACING THE BONDED WIRE CAUSED THE PATIENT'S ALLERGIC REACTION. AS WE DON'T HAVE ANY INFORMATION OTHER THAN NO KNOWN ALLERGIES, 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. 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 (B)(6) 2024.
WHO: THE DOCTOR CONTACTED ULAB REGARDING THE POSSIBLE ALLERGIC REACTION. WHAT: (B)(6) AT THE OFFICE CALLED TO SAY THAT THE PATIENT SEEMED TO HAVE AN ALLERGIC REACTION. WHEN: (B)(6) 2024 WHERE: RETAINERS WERE IN THE PATIENT'S POSSESSION AT THE TIME OF THE POSSIBLE ALLERGIC REACTION. PER DOCTOR, THE PATIENT HAD NO KNOWN ALLERGIES, BUT EXPERIENCED A SWOLLEN TONGUE AND LIPS. ASKED IF THE PATIENT HAD DONE ALIGNER TREATMENT THROUGH ANOTHER COMPANY AND (B)(6) STATED THAT THE PATIENT HAS A BONDED WIRE ON THEIR LOWER ARCH. WHY: NO RMA NO MANUFACTURING DEFECTS. INSPECTED AT QA03 BY #97 ON (B)(6) 2024. PER DISCUSSION IN THE COMPLAINT MEETING ON (B)(6) 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) OR IF MATERIALS USED BY THE OTHER COMPANY WHEN PLACING THE BONDED WIRE CAUSED THE PATIENT'S ALLERGIC REACTION. AS WE DON'T HAVE ANY INFORMATION OTHER THAN NO KNOWN ALLERGIES, 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. 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 (B)(6) 2024.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 173939 | ULAB SYSTEMS DENTAL ALIGNER | FG0094, ULAB SYSTEMS ALIGNER KIT | NXC | ULAB SYSTEMS | FG0094 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other | FG0094, ULAB SYSTEMS USMILE ALIGNER KIT |