InjuryEFS
WATER PIK SONIC FUSION
Received Dec 21, 2022 · Event occurred Dec 9, 2022
Report 0001712259-2022-00012 · MDR key 16024555
Device
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
Male
- Skin Inflammation/ Irritation
- Skin Inflammation/ Irritation
Narrative
Description of Event or Problem
CUSTOMER CLAIMS USE OF SONIC FUSION CAUSE INJURY TO ROOF OF MOUTH. CUSTOMER CLAIMS INCIDENT REQUIRED VISIT TO EMERGENCY ROOM AND TREATMENT. CUSTOMER IS SEEKING REIMBURSEMENT BUT HAS BEEN UNABLE/ UNWILLING TO PROVIDE ANY MEDICAL DOCUMENTATION, ETC. CUSTOMER NOTIFIED PRODUCT RETURN IS REQUIRED TO SUPPORT CLAIM.
Remedial action
- Other