BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LISTERINE TOOTHBRUSH ULTRA WHITE MEDIUM 1S

    MDR report key: 2873388 · Received December 14, 2012

    Report

    Report Number
    2214133-2012-00404
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Report Date
    November 27, 2012
    Manufacturer
    SKILLMAN CONTRACT
    Product Code
    EFW
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOREIGN REPORT IS BEING SUBMITTED ON (B)(4) 2012, FOR A DEVICE PRODUCT THAT IS CONSIDERED SAME/SIMILAR TO A US MARKETED DEVICE (REACH TOTAL CARE PLUS WHITEN TBRUSH MED). THIS CLOSES OUT THIS REPORT UNLESS ADDITIONAL FOLLOW UP INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2012 FROM A CONSUMER (AGE AND GENDER UNSPECIFIED) REPORTING ON SELF FROM (B)(6). ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING LISTERINE TOOTHBRUSH ULTRA WHITE MEDIUM 1S, FOR DENTAL CLEANING (ROUTE: DENTAL, LOT NUMBER 00612SG1, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER THREE TO FOUR TIMES OF USAGE, THE HANDLE OF TOOTHBRUSH SNAPPED. THE CONSUMER MENTIONED THE USAGE OF THE DEVICE IN THE PAST WITHOUT ANY ADVERSE EVENT. THIS REPORT HAD NO ADVERSE EVENT AND THE ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. THIS REPORT WAS CONSIDERED A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LISTERINE TOOTHBRUSH ULTRA WHITE MEDIUM 1S TOOTHBRUSH, MANUAL EFW SKILLMAN CONTRACT UWHME72856 00612SG1

    Patients

    Seq Age Sex Outcome Treatment
    1