inforMED
InjuryEFS

WATERPIK WATER FLOSSER

Received Jun 20, 2018 · Event occurred May 25, 2018

Report 0001712259-2018-00003 · MDR key 7620618

Device

Generic name

Oral Irrigator

Manufacturer

Water Pik, Inc.

Model number

WP-562

Product problems

  • Detachment Of Device Component
  • Crack
  • Leak/Splash

Patient

40 YR

  • Tinnitus
  • Injury
  • Tinnitus
  • Injury

Narrative

Additional Manufacturer Narrative

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

Description of Event or Problem

PER THE CUSTOMER....CLAIMS DEVICE FAILED DURING USE, FRONT FACEPLATE POPPED OFF AND HANDLE IS CRACKED OPEN EXPOSING PRESSURE SETTING AND CHARGE INDICATOR DIODES. CUSTOMER DENIES ANY USE OF ADDITIVES OR POTENTIAL FOR CHEMICAL ATTACK OR ANY OTHER MISUSE. CUSTOMER IDENTIFIED THIS CAUSED A MARK ON HIS HAND AND EARS TO RING BUT NOTHING MORE SEVERE. HE IS NOT SEEKING RESTITUTION FOR ANY INJURY. CUSTOMER CLAIMS UNIT LEAKED AFTER USE FROM DAY ONE AND DESCRIBES THE PUMP AS INCONSISTENT. UNIT HAS BEEN USED SINCE (B)(6) 2017.