BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LISTERINE TOOTHBRUSH ULTRA WHITE FIRM

    MDR report key: 2884759 · Received December 26, 2012

    Report

    Report Number
    2214133-2012-00411
    Event Type
    Malfunction
    Date Received
    December 26, 2012
    Report Date
    December 3, 2012
    Manufacturer
    NI
    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 (B)(4) 2013, FOR A DEVICE PRODUCT THAT IS CONSIDERED SAME/SIMILAR TO A US MARKETED DEVICE (REACH TOTAL CARE PLUS WHITEN TOOTHBRUSH MED). THIS CLOSES OUT THIS REPORT UNLESS ADDITIONAL FOLLOW UP INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INITIAL SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2012 FROM A CONSUMER (AGE AND GENDER UNSPECIFIED) REPORTING ON SELF FROM (B)(6). FOLLOW-UP INFORMATION RECEIVED ON (B)(4) 2012 CONFIRMED THAT THE PRODUCT INVOLVED IN THIS REPORT WAS IDENTIFIED AS SAME/SIMILAR TO A US DEVICE PRODUCT. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING LISTERINE TOOTHBRUSH ULTRA WHITE FIRM 1S, FOR DENTAL CLEANING (ROUTE: DENTAL, LOT NUMBER 13712SG, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER FIVE DAYS OF USE, THE TOOTHBRUSH SNAPPED IN THE MIDDLE. 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.

    Description of Event or Problem · 1

    INITIAL SPONTANEOUS REPORT WAS RECEIVED ON (B)(4) 2012 FROM A CONSUMER (AGE AND GENDER UNSPECIFIED) REPORTING ON SELF FROM (B)(6). FOLLOW-UP INFORMATION RECEIVED ON (B)(4) 2012 CONFIRMED THAT THE PRODUCT INVOLVED IN THIS REPORT WAS IDENTIFIED AS SAME/SIMILAR TO A US DEVICE PRODUCT. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING LISTERINE TOOTHBRUSH ULTRA WHITE FIRM 1S, FOR DENTAL CLEANING (ROUTE: DENTAL, LOT NUMBER 13712SG, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER FIVE DAYS OF USE, THE TOOTHBRUSH SNAPPED IN THE MIDDLE. 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)(4) 2013. THE LOT NUMBER OF THE DEVICE WAS UPDATED FROM 13712SG TO 13712SGM2. BASED ON VISUAL INSPECTION AND ANALYSIS OF RECEIVED SAMPLE, THE CLAIMED TOOTHBRUSH WAS BROKEN. THE TUFTS WERE SCRUBBY. THE HANDLE BREAKAGE WAS AT THE THINNEST POINT OF THE HANDLE. THE TEST REQUIREMENTS TO PASS ALL VALIDATION AND DEVICE SPECIFICATIONS WERE OVERBEND TEST AND HEAD BREAK TEST TO SOLVE MEDICAL COMPLAINTS. DURING THE OVERBEND TEST OF VALIDATION, NO TOOTHBRUSH WAS BROKEN. THE CLAIMED TOOTHBRUSH HAD BEEN MANUFACTURED ACCORDING TO THE SPECIFICATION. NO MANUFACTURING ERROR HAS BEEN DETECTED. THIS REPORT REMAINS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LISTERINE TOOTHBRUSH ULTRA WHITE FIRM TOOTHBRUSH, MANUAL EFW NI UWHFI72857 13712SGM2

    Patients

    Seq Age Sex Outcome Treatment
    1