BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REACH TOTAL CARE PLUS WHITENING TOOTHBRUSH

    MDR report key: 2944857 · Received February 5, 2013

    Report

    Report Number
    2214133-2013-00019
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 25, 2013
    Manufacturer
    SKILLMAN CONTRACT
    Product Code
    EFW
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS 05-FEB-2013. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A (B)(6) CAUCASIAN FEMALE CONSUMER REPORTING ON SELF FROM (B)(6). THE CONSUMER DID NOT HAVE ANY KNOWN MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. OTHER HISTORY INCLUDED ALCOHOL CONSUMPTION AND SMOKING. ON (B)(6) 2013, THE CONSUMER STARTED USING REACH TOTAL CARE PLUS WHITENING TOOTHBRUSH TO BRUSH TEETH THREE TIMES A DAY (ROUTE DENTAL, LOT NUMBER 10811SG1, EXPIRATION DATE UNSPECIFIED). ON TWENTY FIRST DAY, WHILE USING, THE TOOTHBRUSH BROKE WHERE SHE PUT THUMB AND HURT HER HAND AND SHE DID NOT USE THE DEVICE ANY FURTHER. SHE USED POLYSPORIN (POLYMYXIN B AND BACITRACIN) TO TREAT THE EVENT. THE EVENT WAS RESOLVING. THE REPORT WAS ASSESSED AS NON SERIOUS. THE COMPANY CAUSALITY WAS ASSESSED AS POSSIBLE. THIS REPORT WAS CONSIDERED AS A REPORTABLE MALFUNCTION CASE IN UNITED STATES.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A (B)(6) FEMALE CONSUMER REPORTING ON SELF FROM (B)(6). THE CONSUMER DID NOT HAVE ANY KNOWN MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. OTHER HISTORY INCLUDED ALCOHOL CONSUMPTION AND SMOKING. ON (B)(6) 2013, THE CONSUMER STARTED USING REACH TOTAL CARE PLUS WHITENING TOOTHBRUSH TO BRUSH TEETH THREE TIMES A DAY (ROUTE DENTAL, LOT NUMBER 10811SG1, EXPIRATION DATE UNSPECIFIED). ON TWENTY FIRST DAY, WHILE USING, THE TOOTHBRUSH BROKE WHERE SHE PUT THUMB AND HURT HER HAND AND SHE DID NOT USE THE DEVICE ANY FURTHER. SHE USED POLYSPORIN (POLYMYXIN B AND BACITRACIN) TO TREAT THE EVENT. THE EVENT WAS RESOLVING. THE REPORT WAS ASSESSED AS NON SERIOUS. THE COMPANY CAUSALITY WAS ASSESSED AS POSSIBLE. THIS REPORT WAS CONSIDERED AS A REPORTABLE MALFUNCTION CASE IN UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013. THE CONSUMER REPORTED LOT NUMBER WAS NOT CONFIRMED AS A VALID LOT NUMBER FOR THE REPORTED PRODUCT. THE LOT NUMBER REPORTED WAS THE PACKAGED LOT NUMBER. FAMILY TREND ANALYSIS WAS CONDUCTED FOR THIS COMPLAINT AND REVIEW OF THE COMPLAINT DATA ASSOCIATED WITH THE COMPLAINTS WITH USE IDENTIFIED A TREND FOR THIS PRODUCT FAMILY. THE COMPLAINT SAMPLE WAS NOT RETURNED. THE CONSUMER DID NOT REPORT A VALID LOT NUMBER FOR INVESTIGATION; THEREFORE A REVIEW OF COMPLAINT TRENDS BY LOT COULD NOT BE PERFORMED. A REVIEW OF THE COMPLAINT DATA ASSOCIATED WITH THIS COMPLAINT CATEGORY DID NOT IDENTIFY AN ADVERSE TREND FOR THIS PRODUCT FAMILY. ALL PRODUCT BATCHES MET IN-PROCESS AND FINAL RELEASE SPECIFICATIONS PRIOR TO DISTRIBUTION. THIS REPORT REMAINS NON SERIOUS. THIS REPORT REMAINS REPORTABLE MALFUNCTION CASE IN UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49303 REACH TOTAL CARE PLUS WHITENING TOOTHBRUSH TOOTHBRUSH, MANUAL EFW SKILLMAN CONTRACT 6260095386 10811SG1

    Patients

    Seq Age Sex Outcome Treatment
    1