InjuryEFS
WATER PIK SONIC FUSION
Received Oct 6, 2021 · Event occurred Sep 21, 2021
Report 1712259-2021-00006 · MDR key 12586682
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Tooth Fracture
- Tooth Fracture
Narrative
Description of Event or Problem
CUSTOMER HAD BEEN USING THE UNIT ON A CRACKED TOOTH, SHE STATED SHE HAD THE TOOTH FOR A FEW YEARS. PRIOR TO THE OCCURRENCE, SHE USED THE MACHINE 3-4 TIMES A WEEK AT A SETTING OF 3 OR 4. SHE STATED THAT SHE VISITED HER DENTIST AND ORTHODONTIST REGULARLY. WE HAVE REFUNDED HER FOR THE UNIT, AT THIS TIME SHE IS SEEKING COMPENSATION FOR HER MEDICAL EXPENSES.
Remedial action
- Replace