InjuryEEG
BRIGHTBYTE PRO WHITENING KIT
Received May 21, 2025
Report 3031789024-2025-02567 · MDR key 22059147
Device
Generic name
Heat Source For Bleaching Teeth
Manufacturer
Jiangxi Dentalbright Tech Co., LtdCatalog number
BYTEBBP
Product problems
- Patient-Device Incompatibility
- Patient-Device Incompatibility
Patient
NA · Unknown
- Deformity/ Disfigurement
- Deformity/ Disfigurement
Narrative
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.
Description of Event or Problem
PATIENT REPORTED THERE HAS BEEN DAMAGE TO THEIR ENAMEL DUE TO THE WHITENING PRODUCT THAT WAS SENT WITH THE ALIGNERS.