inforMED
InjuryEFS

WATER PIK AQUARIUS WATER FLOSSER

Received Oct 23, 2020 · Event occurred Oct 19, 2020

Report 1712259-2020-00007 · MDR key 10730313

Device

Generic name

Oral Irrigator

Manufacturer

Water Pik Inc

Model number

WP-660

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

Not reported

  • Tooth Fracture
  • Tooth Fracture

Narrative

Description of Event or Problem

CUSTOMER STATED SHE DOESN'T KNOW IF SHE THINKS THIS WAS BECAUSE OF A PRODUCT DEFECT OR NOT. SAID SHE HAS NOT SEEN THE DENTIST YET BUT HAS CALLED THE OFFICE AND HE WILL BE OUT FOR 2 WEEKS- SAID SHE IS HAVING A HARD TIME EATING AND CAN ONLY EAT WITH THE ONE SIDE OF HER MOUTH- WANTS TO BE COMPENSATED FOR THE DAMAGE" SPOKE WITH CUSTOMER - BRIDGE WAS SEATED (B)(6) 2019 & IS LOCATED IN THE LOWER LEFT BACK OF HER MOUTH. SHE WAS USING THE JT "GENERAL USE" TIP - COULD NOT REMEMBER WHAT PRESSURE SETTING SHE WAS USING - STATED SHE HAD "LOOKED OVER THE MANUAL" BUT COULD NOT REMEMBER IF SHE HAD READ IT. SHE STATED SHE "THINKS" SHE SAW THE DENTIST "LAST MONTH" ((B)(6) 2020). AT THAT TIME NO PROBLEMS WERE DETECTED - SHE HAS NOT BEEN TO THE DENTIST SINCE THE ISSUE OCCURRED AS HE IS "OUT OF THE OFFICE FOR 2 WEEKS" - WHILE USING SHE "FELT SOMETHING LOOSE" AND AFTER SHE PICKED OUT A PIECE OF HER BRIDGE FROM HER MOUTH (SHE STILL HAS THIS PIECE). PRIOR TO USE SHE HAD NOT NOTICED ANYTHING AMISS WITH THE BRIDGE.