BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIST TB ULTRA WHITE FIRM PR-009305 EU

    MDR report key: 2843262 · Received November 22, 2012

    Report

    Report Number
    2214133-2012-00366
    Event Type
    Malfunction
    Date Received
    November 22, 2012
    Report Date
    November 7, 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 (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.

    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) 2012, FROM A REPORTER REPORTING ON A MALE CONSUMER (AGE UNSPECIFIED) FROM THE (B)(6). THE MEDICAL HISTORY OF THE CONSUMER AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING LISTERINE TOOTHBRUSH ULTRA WHITE FIRM 1S, FOR DENTAL CLEANING (ROUTE: DENTAL, LOT NUMBER 35411SGH3; FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, THE TOOTHBRUSH SNAPPED IN HALF, ACCIDENTALLY WENT INTO HIS EYE ALONG WITH TOOTHPASTE AND POSSIBLY SCRATCHED HIS CORNEA. THE ACTION TAKEN WITH THE DEVICE AND OUTCOME OF THE EVENTS WERE UNKNOWN. THIS REPORT HAD NON-SERIOUS EVENT. THE COMPANY CAUSALITY WAS ASSESSED AS POSSIBLE. THIS REPORT WAS CONSIDERED 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 REPORTER REPORTING ON A MALE CONSUMER (AGE UNSPECIFIED) FROM (B)(6). THE MEDICAL HISTORY OF THE CONSUMER AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING LISTERINE TOOTHBRUSH ULTRA WHITE FIRM 1S, FOR DENTAL CLEANING (ROUTE: DENTAL, LOT NUMBER 35411SGH3; FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, THE TOOTHBRUSH SNAPPED IN HALF, ACCIDENTALLY WENT INTO HIS EYE ALONG WITH TOOTHPASTE AND POSSIBLY SCRATCHED HIS CORNEA. THE ACTION TAKEN WITH THE DEVICE AND OUTCOME OF THE EVENTS WERE UNKNOWN. THIS REPORT HAD NON-SERIOUS EVENT. THE COMPANY CAUSALITY WAS ASSESSED AS POSSIBLE. THIS REPORT WAS CONSIDERED A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013. THE RETURNED SAMPLE OR PHOTOS OF SAMPLE WERE NOT PROVIDED FOR INVESTIGATION BY THE CONSUMER AS OF (B)(6) 2013. THE AREA OF BREAKAGE WAS UNKNOWN. IF THE TOOTHBRUSH BROKE AND WENT UP INTO THE EYE OF THE CONSUMER, THE BRUSH MUST BEEN BROKEN COMPLETELY OFF. THIS EFFECT WAS NEVER OBSERVED BEFORE IN DESPITE OF BREAKAGES. 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 FIRST MOLD AND SECOND MOLD, NO TOOTHBRUSH WAS BROKEN. JOHNSON AND JOHNSON GOT THE SAME RESULT WITH A SIMILAR TEST THAT WAS A BASE FOR DEVICE RELEASE. A CHANGE OF THE BASIC HANDLE MATERIAL FROM MOPLEN (POLYPROPYLENE) TO DOMOLEN (POLYPROPYLENE) HAD BEEN VALIDATED AND RELEASED ON 12-SEP-2012 BY JOHNSON AND JOHNSON. THIS REPORT REMAINS NON-SERIOUS. THIS REPORT REMAINS 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 35411SGH3

    Patients

    Seq Age Sex Outcome Treatment
    1