inforMED
MalfunctionEFS

HYDROFLOSS WATER FLOSSER

Received May 18, 2023 · Event occurred Mar 24, 2023

Report MW5117713 · MDR key 16963051

Device

Generic name

Unit, Oral Irrigation

Model number

76118.034

Product problems

  • Material Fragmentation
  • Decrease in Pressure
  • Product Quality Problem
  • Obstruction of Flow

Patient

62 YR · Female

  • Foreign Body In Patient
  • Foreign Body In Patient

Narrative

Description of Event or Problem

I PURCHASED A HYDROFLOSS WATER FLOSSER UNIT ON (B)(6) 2022, FOR TREATING MILD PERIODONTITIS. IT WORKED AS INTENDED FOR SOME MONTHS, BUT SUDDENLY THE WATER PRESSURE DECREASED AND IT WAS NO LONGER EFFECTIVE. I NOTICED A SMALL PIECE OF PLASTIC IN MY MOUTH AFTER USING IT, AND AN OTHER SMALL PIECE OF PLASTIC IN THE NOZZLE. I CONTACTED ORAL CARE TECHNOLOGIES (B)(4) AND ASKED HIM TO SEND A REPLACEMENT PUMP, SINCE THE UNIT WAS UNDER A 1 YEAR WARRANTY. HE DECLINED. I HAVE MULTIPLE TIMES TRIED TO CONTACT HIM REGARDING THE DEFECTIVE MATERIAL IN THE PUMP, BUT HE DOES NOT RESPOND. THE HYDROFLOSS WATER FLOSSER SHOULD BE RECALLED DUE TO DEFECTIVE MATERIAL AND FAILING PUMPS SHOULD BE EITHER REPLACED BY ORAL CARE TECHNOLOGIES, INC., OR PUMPS SHOULD BE SHIPPED TO CONSUMERS FOR REPLACEMENT. THE SMALL PLASTIC PIECES ARE SHARP AND COULD CAUSE INJURY IN THE MOUTH OR ACCIDENTALLY SWALLOWED. THE PUMP IS EASY TO REPLACE AND THE COMPANY EVEN PROVIDES VIDEO INSTRUCTIONS ONLINE. IT APPEARS TO BE A WIDESPREAD PROBLEM SINCE ACCORDING TO IMPORT RECORDS, ORAL CARE TECHNOLOGIES HAVE IMPORTED A LARGE AMOUNT OF PUMP ASSEMBLIES FOR SERVICE.