BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REACH TOOTHBRUSH UNSPECIFIED

    MDR report key: 2843284 · Received November 22, 2012

    Report

    Report Number
    2214133-2012-00394
    Event Type
    Malfunction
    Date Received
    November 22, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 6, 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 CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS (B)(4) 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)(4) 2012, FROM A MALE CONSUMER (AGE UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING REACH TOOTHBRUSH UNSPECIFIED, FOR DENTAL CLEANING (ROUTE DENTAL, LOT NUMBER, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, IN THE NIGHT OF (B)(6) 2012, THE CONSUMER NOTICED THAT THE TOOTHBRUSH BROKE IN HALF WHILE BRUSHING. THE CONSUMER USED THE DEVICE IN THE PAST WITHOUT ANY ISSUE. THIS REPORT HAD NO ADVERSE EVENT AND THE ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. THIS REPORT WAS CONSIDERED AS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2012. BASED UPON AN ACCEPTABLE MANUFACTURING AND FACILITY ISSUE REVIEW, DUE TO LACK OF A PRODUCT NAME, LOT NUMBER AND SAMPLE, AND NO ADVERSE TRENDS THIS COMPLAINT COULD NOT BE CONFIRMED AND A ROOT CAUSE COULD NOT BE DETERMINED FOR THIS COMPLAINT. COMPLAINT TRENDS WOULD CONTINUE TO BE MONITORED. 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 MALE CONSUMER (AGE UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING REACH TOOTHBRUSH UNSPECIFIED, FOR DENTAL CLEANING (ROUTE DENTAL, LOT NUMBER, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, IN THE NIGHT OF (B)(6) 2012, THE CONSUMER NOTICED THAT THE TOOTHBRUSH BROKE IN HALF WHILE BRUSHING. THE CONSUMER USED THE DEVICE IN THE PAST WITHOUT ANY ISSUE. THIS REPORT HAD NO ADVERSE EVENT AND THE ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. THIS REPORT WAS CONSIDERED AS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REACH TOOTHBRUSH UNSPECIFIED TOOTHBRUSH, MANUAL EFW SKILLMAN CONTRACT RCTBUNUS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1