inforMED
InjuryEFS

WATERPIK WATER FLOSSER

Received Oct 6, 2016 · Event occurred Sep 22, 2016

Report 0001712259-2016-00004 · MDR key 6002891

Device

Generic name

Oral Irrigator

Manufacturer

Water Pik, Inc.

Model number

WP-140

Product problems

  • Use of Device Problem
  • Improper or Incorrect Procedure or Method

Patient

40 YR

  • Injury
  • Injury

Narrative

Additional Manufacturer Narrative

UNIT IN QUESTION HAS NOT YET BEEN RETURNED FOR TESTING AND EVALUATION. DEVICE IN QUESTION HAS NOT BEEN RECEIVED.

Description of Event or Problem

PER THE CUSTOMER....CLAIMS TO HAVE SUSTAINED INJURY AT THE TIME OF INITIAL USE, UNIT WAS SET TO MAXIMUM PRESSURE SETTING TO PRIME AS PER PRODUCT LITERATURE. CUSTOMER DID NOT LESSEN PRESSURE WHEN ATTEMPTING TO USE THE PRODUCT AND CLAIMS TO HAVE EXPERIENCED BLEEDING GUMS. CUSTOMER CLAIMS BACTERIAL PNEUMONIA/INFECTION WERE SUSTAINED DUE TO USE OF THE PRODUCT. CUSTOMER ACKNOWLEDGES THAT THE PRODUCT WAS NOT USED AS INSTRUCTED. CUSTOMER EMAILED HER DENTIST, THE DENTIST WROTE BACK AND TOLD HER THAT SHE PROBABLY DID NOT USE THE DEVICE CORRECTLY AND DID NOT AGREE WITH HER SELF-DIAGNOSIS ABOUT THE BACTERIAL INFECTION.