BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROFLOSS WATER FLOSSER

    MDR report key: 16963051 · Received May 18, 2023

    Report

    Report Number
    MW5117713
    Event Type
    Malfunction
    Date Received
    May 18, 2023
    Date of Event
    March 24, 2023
    Report Date
    May 16, 2023
    Manufacturer
    ORAL CARE TECHNOLOGIES, INC.
    Product Code
    EFS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848762 HYDROFLOSS WATER FLOSSER UNIT, ORAL IRRIGATION EFS ORAL CARE TECHNOLOGIES, INC. 76118.034

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female