BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIST TB ULTRA WHITE FIRM PR-009305 EU

    MDR report key: 2843280 · Received November 22, 2012

    Report

    Report Number
    2214133-2012-00391
    Event Type
    Malfunction
    Date Received
    November 22, 2012
    Report Date
    November 8, 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) 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.

    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 FIRM 1S, FOR DENTAL CLEANING (ROUTE: DENTAL, FREQUENCY, LOT NUMBER AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, TOOTHBRUSH SNAPPED WHILE USING. 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) 2012. THE LOT NUMBER WAS TO 13912SG H1. THE RETURNED FIELD SAMPLE WAS RECEIVED ON (B)(4) 2012. BASED ON VISUAL INSPECTION AND ANALYSIS OF RECEIVED SAMPLE, THE CLAIMED TOOTHBRUSH WAS BROKEN AT THE BASIC HANDLE. THE TUFTS WERE DEFORMED. THE HANDLE BREAKAGE WAS AT THE THINNEST POINT OF THE HANDLE. DURING THE OVERBEND TEST OF VALIDATION, NO TOOTHBRUSH WAS BROKEN. CHANGES TO INCREASE HANDLE STABILITY AND AVOID BREAKAGES DURING AN ORDINARY USING OF THE TOOTHBRUSH WERE UNDER EXAMINATION. NO MANUFACTURING ERROR HAS BEEN DETECTED. THIS REPORT REMAINS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.

    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 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). AFTER AN UNSPECIFIED DURATION, TOOTHBRUSH SNAPPED WHILE USING. 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 LIST TB ULTRA WHITE FIRM PR-009305 EU TOOTHBRUSH, MANUAL EFW SKILLMAN CONTRACT UWHFI72857 13912SG H1

    Patients

    Seq Age Sex Outcome Treatment
    1