InjuryEFS
WATER PIK SONIC FUSION
Received Apr 8, 2022 · Event occurred Sep 13, 2021
Report 0001712259-2022-00004 · MDR key 14053202
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Female
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Description of Event or Problem
CUSTOMER RETURNED PRODUCT TO WP CLAIMING USE OF FLOSSER CAUSED DAMAGE TO CUSTOMER'S BRIDGE. CUSTOMER APPROXIMATES PRODUCT HAD BEEN IN USE FOR 8-9 MONTHS; BRIDGE WAS INSTALLED IN EARLY 1980'S. CUSTOMER DID NOT SUBMIT DOCUMENTATION OF REPAIR OR REQUEST COMPENSATION FOR IT; STATED THEY ONLY WANTED TO VERIFY THE DEVICE PERFORMED TO SPECIFICATION. SF-02 PURCHASE PRICE REFUNDED, ISSUED COURTESY (B)(4). CUSTOMER HAS NOT CONTACTED CS SINCE INITIAL SEPTEMBER CONTACT SO IDENTIFYING APPROPRIATE INFORMATION FOR A FILING WAS EXTREMELY DIFFICULT.
Remedial action
- Replace