BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LISTERINE TOOTHBRUSH ULTRA WHITE FIRM 1S

    MDR report key: 3101037 · Received May 9, 2013

    Report

    Report Number
    2214133-2013-00043
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    April 10, 2013
    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

    (B)(4). THE PRODUCT INVOLVED IN THE COMPLAINT WAS DETERMINED TO BE SAME/SIMILAR TO A US DEVICE ON (B)(4) 2013. (B)(4). THIS CLOSES OUT THIS REPORT UNLESS ADDITIONAL FOLLOW UP INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS FOREIGN REPORT IS BEING SUBMITTED (B)(4) 2013, 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) 2013 FROM A REPORTER REPORTING ON A CONSUMER (AGE AND GENDER UNSPECIFIED) FROM THE (B)(6).ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING LISTERINE TOOTHBRUSH ULTRA WHITE FIRM 1S, FOR DENTAL CLEANING (ROUTE: DENTAL, FREQUENCY, LOT NUMBER AND EXPIRATION DATE UNSPECIFIED). WITHIN TWO DAYS OF DEVICE USAGE, THE TOOTHBRUSH SNAPPED.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.ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013BASED ON THE INFORMATION RECEIVED (B)(6) 2013, THE PRODUCT INVOLVED IN THE COMPLAINT WAS DETERMINED TO BE SAME/SIMILAR TO A US DEVICE. (B)(4).THIS REPORT WAS REASSESSED TO BE NON REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A REPORTER REPORTING ON A CONSUMER (AGE AND GENDER UNSPECIFIED) FROM THE (B)(6). ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING LISTERINE TOOTHBRUSH ULTRA WHITE FIRM 1S, FOR DENTAL CLEANING (ROUTE: DENTAL, FREQUENCY, LOT NUMBER AND EXPIRATION DATE UNSPECIFIED). WITHIN TWO DAYS OF DEVICE USAGE, THE TOOTHBRUSH SNAPPED. 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
    203083 LISTERINE TOOTHBRUSH ULTRA WHITE FIRM 1S TOOTHBRUSH, MANUAL EFW SKILLMAN CONTRACT UWHFI72857 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1