InjuryKLE
FUTURABOND U SINGLEDOSE 200
Received Apr 20, 2023 · Event occurred Mar 15, 2023
Report 8010908-2023-00003 · MDR key 16774601
Device
Product problems
- Product Quality Problem
- Product Quality Problem
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
NO DEFECTIVE MATERIAL PROPERTY WAS DETECTED ON THE RETAINED SAMPLE OF THE BATCH CONCERNED. THE PRODUCT WAS NOT RETURNED TO US. IF USED CORRECTLY, DISCOLORATION OF THE TREATED TEETH IS NOT TO BE EXPECTED. NO SIMILAR INCIDENTS ARE KNOWN. OUR INQUIRIES ABOUT THE CIRCUMSTANCES OF THE TREATMENT WERE NOT ANSWERED.
Description of Event or Problem
A DENTIST ALLEGES THAT FUTURABOND U WAS STAINING THE TEETH OF SEVERAL PATIENTS TO A COFFEE BROWN COLOR. IT IS NOT KNOWN IN WHAT WAY AND FOR WHAT INDICATION THE PRODUCT WAS USED. IT IS UNKNOWN IF ANY FOLLOW UP TREATMENT WAS PROVIDED.