BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELEDYNE WATERPIK

    MDR report key: 341761 · Received July 5, 2001

    Report

    Report Number
    MW4003032
    Event Type
    Injury
    Date Received
    July 5, 2001
    Date of Event
    May 30, 2001
    Report Date
    July 5, 2001
    Manufacturer
    TELEDYNE WATERPIK-LOVELAND DIV
    Product Code
    EFS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT SUFFERED GUM INJURY DUE TO FAULTY PRESSURE VALVE. THE COMPLAINANT WENT TO THEIR DENTIST TO HAVE GUMS CHECKED IN 2001. COMPLAINT SYMPTOMS: BLEEDING FROM GUMS. COMPLAINANT PROVIDED ADD'L INFO ABOUT THE INCIDENT AND THE MODEL CODE OF THE DEVICE. ACCORDING TO THE RPTR THEIR FAMILY USED THE WATER PIK FOR ALMOST A YEAR WITHOUT ANY PROBLEM, UNTIL ONE MORNING WHILE BRUSHING THEIR TEETH THE DEVICE PRESSURE SWITCH CHANGED FROM THE LOW SETTING TO THE HIGH SETTING BY ITSELF, CAUSING SCRAPING AND BLEEDING OF THEIR GUMS. RPTR WENT TO THE DENTIST TO HAVE THEIR GUMS CHECKED AND WAS TOLD THERE WASN'T MUCH THEY COULD DO AND TO LET THE HEALING PROCESS COME NATURALLY. THE DENTIST'S OFFICE CONTACTED TELEDYNE AND REPORTED THE INCIDENT. THE RPTR RECEIVED A LETTER OF APOLOGY FROM TELEDYNE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30320 TELEDYNE WATERPIK * EFS TELEDYNE WATERPIK-LOVELAND DIV WP-60W NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO