WATERFLOSSER
Received Oct 21, 2021 · Event occurred Jul 4, 2020
Report 3014658399-2021-01248 · MDR key 12678286
Device
Generic name
Oral Irrigation
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
69 YR
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Additional Manufacturer Narrative
BASED ON THE INFORMATION PROVIDED BY THE PATIENT, THERE IS NO CONCLUSIVE EVIDENCE THAT SUPPORTS OR OPPOSES THE FACT THAT THE WATERFLOSSER CAUSED, CONTRIBUTED, OR WOULD LIKELY CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THIS EVENT IS BEING FILED AS AN MDR SINCE THE PATIENT REPORTED SYMPTOMS OR PHYSIOLOGICAL CONDITIONS RELATED TO DAMAGED CROWN (CRACKED DENTAL RESTORATION/DISLODGED DENTAL RESTORATION). AS PER CAPA # (B)(4) THIS EVENT IS RETROSPECTIVELY BEING REPORTED AND THEREFORE WAS NOT REPORTED WITHIN THE REQUIRED 30-DAYS.
Description of Event or Problem
ON (B)(6) 2020 THE CUSTOMER REPORTED A DISLODGED CROWN WHILE USING THE WATERFLOSSER, THE CUSTOMER WAS NOT ABLE TO PROVIDE THE IMPACTED TOOTH NUMBER. IT IS UNKNOWN IF MEDICAL INTERVENTION WAS REQUIRED. IT IS UNKNOWN IF ALIGNER TREATMENT WAS DISCONTINUED.