inforMED
InjuryEFS

WATER PIK SONIC FUSION

Received Dec 21, 2021 · Event occurred Dec 10, 2021

Report 0001712259-2021-00010 · MDR key 13054286

Device

Generic name

Oral Irrigator

Manufacturer

Water Pik, Inc.

Model number

SF-04

Lot number

21032XXX

Product problems

  • Unintended Electrical Shock
  • Unintended Electrical Shock

Patient

Male

  • Electric Shock
  • Electric Shock

Narrative

Description of Event or Problem

THE CUSTOMER STATED HIS FLOSSER HAD RUN WELL FOR THE LAST FEW WEEKS, HE HAD ONLY PURCHASED IT 3 WEEKS AGO, END OF NOVEMBER. STATED HE DID NOT USE ADDITIVES OR DROP IT. THE HOSE CONNECTION PART FAILED AND WHILE BRUSHING, THE TOOTHBRUSH FELL. (B)(6) STATED THAT WHEN THIS HAPPENED HE SAW ELECTRICAL PARTS AND CLAIMS TO HAVE RECEIVED AN ELECTRICAL SHOCK. CUSTOMER IMAGES DEMONSTRATE DATE CODE ON UNDERSIDE OF FLOSSER AS "21032X" (TRAILING CHARACTERS ARE NOT IN-FRAME). ADDITIONAL DETAILS THAT LED TO ADVERSE EVENT HAVE BEEN REQUESTED. THUS FAR CUSTOMER HAS BEEN UNCOOPERATIVE/UNWILLING TO DISCUSS IN DETAIL. CUSTOMER STATED THEY ONLY WANTED THE DEVICE TO BE REPLACED. PRODUCT RETURN HAS BEEN REQUESTED

Remedial action

  • Replace