MAUDE Adverse Event Report: ULAB SYSTEMS ULAB SYSTEMS USMILE ALIGNER; CLEAR ALIGNER

Model Number FG0094

Device Problems Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 09/28/2023

Event Type  Injury  

Event Description

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 cause of the allergic reaction.Conclusion: patient to try the stage 5-10 aligners in reva material (after the reaction clears-up), as another external factor may be causing the allergic reaction/issue.Per sop0014, mandatory medical device reporting, section 8 (australia), this allergic reaction incident is not significant enough for the australia reportability criteria and will not be reported as an adverse incident to the ulab australian sponsor (emergo) or the relevant australian regulatory authority, per the reporting requirement/timelines and australian medical devices guidelines (argmd), chapter 22 post-market vigilance and monitoring requirements.

Manufacturer Narrative

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 cause of the allergic reaction.Conclusion: patient to try the stage 5-10 aligners in reva material (after the reaction clears-up), as another external factor may be causing the allergic reaction/issue.Per sop0014, mandatory medical device reporting, section 8 (australia), this allergic reaction incident is not significant enough for the australia reportability criteria and will not be reported as an adverse incident to the ulab australian sponsor (emergo) or the relevant australian regulatory authority, per the reporting requirement/timelines and australian medical devices guidelines (argmd), chapter 22 post-market vigilance and monitoring requirements.

• Brand Name: ULAB SYSTEMS USMILE ALIGNER
• Type of Device: CLEAR ALIGNER
• Manufacturer (Section D): ULAB SYSTEMS; 7005 appling farms parkway; memphis TN 38133
• Manufacturer (Section G): ULAB SYSTEMS; 7005 appling farms parkway; memphis TN 38133
• Manufacturer Contact: shawn forsythe ; 7005 appling farms parkway; memphis, TN 38133 ; 8669008522
• MDR Report Key: 18220385
• MDR Text Key: 329157094
• Report Number: 3017155477-2023-00008
• Device Sequence Number: 1
• Product Code: NXC
• UDI-Device Identifier: 00860002380094
• UDI-Public: 00860002380094
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K192596N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FG0094
• Device Catalogue Number: N/A
• Device Lot Number: JRN10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FG0094, ULAB SYSTEMS USMILE DENTAL ALIGNER KIT
• Patient Outcome(s): Other
• Patient Sex: Male