BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REACH TOTAL CARE MULTIACTION TOOTHBRUSH USA

    MDR report key: 2852492 · Received November 30, 2012

    Report

    Report Number
    2214133-2012-00401
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Report Date
    November 24, 2012
    Manufacturer
    SKILLMAN CONTRACT
    Product Code
    EFW
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS (B)(4) 2012. THIS IS A FOLLOW UP SUBMISSION FOR THE SECOND PRODUCT IN THIS CASE. THE MANUFACTURER REPORT NUMBER FOR THIS SUBMISSION IS 2214133-2012-00401. THE MANUFACTURER REPORT NUMBER FOR THE FIRST PRODUCT IN THIS CASE IS 2214133-2012-00400. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS AN INITIAL SUBMISSION FOR THE SECOND PRODUCT IN THIS CASE. THE MANUFACTURER REPORT NUMBER FOR THIS SUBMISSION IS 2214133-2012-00401. THE MANUFACTURER REPORT NUMBER OF INITIAL SUBMISSION FOR THE FIRST PRODUCT IN THIS CASE IS 2214133-2012-00400. 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) 2012 FROM A CONSUMER (AGE AND GENDER UNSPECIFIED) REPORTING FOR SELF FROM (B)(6). ON AN UNSPECIFIED DATE IN 2012, THE CONSUMER STARTED USING REACH TOTAL CARE MULTIACTION TOOTHBRUSH, FOR DENTAL CLEANING (ROUTE DENTAL, FREQUENCY, LOT NUMBER AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, THE TOOTHBRUSH BROKE JUST ABOVE THE HOLE, CLOSEST TO THE BRISTLES. THE CONSUMER EXPERIENCED THE SAME WITH TWO TOOTHBRUSHES AND BOTH THE TOOTHBRUSHES LASTED FOR LESS THAN A MONTH. 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

    THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2012 FROM A CONSUMER (AGE AND GENDER UNSPECIFIED) REPORTING FOR SELF FROM (B)(6). ON AN UNSPECIFIED DATE, IN 2012, THE CONSUMER STARTED USING REACH TOTAL CARE MULTIACTION TOOTHBRUSH, FOR DENTAL CLEANING (ROUTE DENTAL, FREQUENCY, LOT NUMBER AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, THE TOOTHBRUSH BROKE JUST ABOVE THE HOLE, CLOSEST TO THE BRISTLES. THE CONSUMER EXPERIENCED THE SAME WITH TWO TOOTHBRUSHES AND BOTH THE TOOTHBRUSHES LASTED FOR LESS THAN A MONTH. 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. NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. BASED UPON AN ACCEPTABLE PRODUCT AND MANUFACTURING HISTORY REVIEW, DUE TO LACK OF A LOT NUMBER AND SAMPLE AND NO ADVERSE TRENDS A ROOT CAUSE COULD NOT BE DETERMINED FOR THIS COMPLAINT. THE COMPLAINT TRENDS WOULD CONTINUE TO BE MONITORED. THIS REPORT REMAINS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REACH TOTAL CARE MULTIACTION TOOTHBRUSH USA TOOTHBRUSH, MANUAL EFW SKILLMAN CONTRACT RETCATUS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1