MAUDE Adverse Event Report: JIANGXI DENTALBRIGHT TECH CO., LTD BRIGHTBYTE PRO WHITENING KIT; HEAT SOURCE FOR BLEACHING TEETH

Catalog Number	BYTEBBP
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.
Event or Problem Description
Patient reported there has been damage to their enamel due to the whitening product that was sent with the aligners.

• Brand Name: BRIGHTBYTE PRO WHITENING KIT
• Common Device Name: HEAT SOURCE FOR BLEACHING TEETH
• Manufacturer (Section D): JIANGXI DENTALBRIGHT TECH CO., LTD; makou industrial park; jiujiang jiangxi 33030 0; CH 330300
• MDR Report Key: 22059147
• Report Number: 3031789024-2025-02567
• Device Sequence Number: 20743014
• Product Code: EEG
• UDI-Device Identifier: 00850017524088
• UDI-Public: 00850017524088
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2025

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 Catalogue Number: BYTEBBP
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/05/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (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: Disability
• Patient Sex: Unknown