MalfunctionEFS

WATER PIK NANOL WATER FLOSSER

Received Aug 11, 2023 · Event occurred Jul 31, 2023

Report 0001712259-2023-00013 · MDR key 17515148

Device

Generic name

Oral Irrigator

Manufacturer

Water Pik Inc.

Model number

WP-310

Lot number

190518AJ

Product problems

Material Fragmentation
Material Fragmentation

Patient

Male

Sore Throat
Sore Throat

Narrative

Description of Event or Problem

CUSTOMER STATED WAS USING UNIT ON MID-PRESSURE AND BACK CAP PIECE OF TB-100 TIP CAME OFF RESULTING IN BEING SWALLOWED. CLAIMS THAT THROAT IS NOW GETTING SORE

Remedial action

Patient Monitoring