MAUDE Adverse Event Report: ENVISTA (SUZHOU) MEDICAL DEVICE SPARK ADVANCED

Model Number	728-3032
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Inflammation (1932); Itching Sensation (1943)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient had allergic reaction to the aligners.The patient refers itching at her tongue, palate and buccal mucosa.She has also experienced swelling and dryness of her lips since she started with the new set of aligners.Based on doctor's professional opinion, it is considered a serious injury.The symptoms started 2 or 3 days after using the aligners.Patient seeked medical attention with a dermatologist.Diagnosis was not provided.Patient was referral to a maxilofacial surgeon.Patient will have a follow up visit in one (1) week.It was prescripted acyclovir.No information was provided if patient is fully recovered.

• Brand Name: SPARK ADVANCED
• Common Device Name: SPARK ADVANCED
• Manufacturer (Section D): ENVISTA (SUZHOU) MEDICAL DEVICE; 1st floor, 2nd floor building; 18#, no. 8 jinfeng road; suzhou, jiangsu 21516 3; CH 215163
• Manufacturer (Section G): ENVISTA (SUZHOU) MEDICAL DEVICE; 1st floor, 2nd floor building; 18#, no. 8 jinfeng road; suzhou, jiangsu 21516 3; CH 215163
• Manufacturer Contact: procoro herrera ; 200 s kraemer blvd; brea, CA 92821 ; 7148174396
• MDR Report Key: 19464162
• Report Number: 2016150-2024-00006
• Device Sequence Number: 15313832
• Product Code: NXC
• UDI-Device Identifier: 00889989084863
• UDI-Public: 00889989084863
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 06/04/2024

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 Model Number: 728-3032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Sex: Female