BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSODYNE MULTI-ACTION TOOTHBRUSH

    MDR report key: 5885416 · Received August 18, 2016

    Report

    Report Number
    9615008-2016-00010
    Event Type
    Injury
    Date Received
    August 18, 2016
    Report Date
    August 8, 2016
    Manufacturer
    M + C SCHIFFER GMBH
    Product Code
    EFW
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT # 9615008-2016-00010 IS ASSOCIATED WITH ARGUS CASE (B)(4), SENSODYNE MULTI-ACTION TOOTHBRUSH. SENSODYNE MULTI-ACTION TOOTHBRUSH IS MARKETED AS SENSODYNE PRONAMEL TOOTHBRUSH IN THE US. NO SAMPLE WAS RECEIVED FOR FURTHER INVESTIGATION, FOR THE COMPLAINT OF LACK EFFICACY; NO FURTHER CAUSE ANALYSIS CAN BE PROVIDED DUE TO LACK KNOWLEDGE OF CONSUMER'S USE HABIT. BOTH DESIGN AND MANUFACTURING OF MENTIONED TOOTHBRUSHES ARE CONFORMED TO GSK SPECIFICATION. NO ASSOCIATION BETWEEN TOOTHBRUSH QUALITY AND COMPLAINT CAN BE IDENTIFIED. BESIDES, NO SIMILAR COMPLAINT HAS BEEN RECEIVED FROM MARKET. ON THE CONDITION THAT NO DEFECT SAMPLE OR BATCH INFO CAN BE PROVIDED FOR FURTHER INVESTIGATION, THE COMPLAINT IS RECOMMENDED TO BE CLOSED AS UNSUBSTANTIATED, AND COMPLAINT WILL BE RE-OPENED ONCE SAMPLE IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS ASSOCIATED WITH (B)(4), SENSODYNE MULTI-ACTION TOOTHBRUSH. SENSODYNE MULTI-ACTION TOOTHBRUSH IS MARKETED AS SENSODYNE PRONAMEL TOOTHBRUSH IN THE US.

    Description of Event or Problem · 1

    CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF OPEN HEART SURGERY IN A (B)(6)-YEAR-OLD FEMALE PATIENT WHO RECEIVED SENSODYNE UNKNOWN TOOTHPASTE FOR DRUG USE FOR UNKNOWN INDICATION. CO-SUSPECT PRODUCTS INCLUDED GSK TOOTHBRUSH (SENSODYNE MULTI-ACTION TOOTHBRUSH) TOOTHBRUSH FOR DRUG USE FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED SENSODYNE UNKNOWN AT AN UNKNOWN DOSE AND FREQUENCY AND SENSODYNE MULTI-ACTION TOOTHBRUSH AT AN UNKNOWN DOSE AND FREQUENCY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING SENSODYNE UNKNOWN AND SENSODYNE MULTI-ACTION TOOTHBRUSH, THE PATIENT EXPERIENCED OPEN HEART SURGERY (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND PRODUCT COMPLAINT. SENSODYNE UNKNOWN WAS CONTINUED WITH NO CHANGE. THE ACTION TAKEN WITH SENSODYNE MULTI-ACTION TOOTHBRUSH WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE OPEN HEART SURGERY WAS RECOVERED/RESOLVED AND THE OUTCOME OF THE PRODUCT COMPLAINT WAS UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE OPEN HEART SURGERY TO BE RELATED TO SENSODYNE UNKNOWN AND SENSODYNE MULTI-ACTION TOOTHBRUSH. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE PRODUCT COMPLAINT TO BE RELATED TO SENSODYNE MULTI-ACTION TOOTHBRUSH. ADDITIONAL DETAILS: REPORT RECEIVED FROM CONSUMER. THE CONSUMER REPORTED THAT SHE HAD RECENTLY UNDERGONE OPEN HEART SURGERY AND MENTIONED THAT SHE HAD BEEN USING SENSODYNE TOOTHPASTE FOR YEARS. THE CONSUMER REPORTED THAT SHE HAS A TOOTHBRUSH SHE USES FOR HER BACK TEETH. THE CONSUMER REPORTED THAT SHE FINDS THE SENSODYNE MULTI ACTION TOOTHBRUSH IS NOT GETTING THE BACK OF HER TEETH CLEAN. THE CONSUMER STATED THAT SHE DOES NOT HAVE A LOT OF CAVITIES. NO CONSENT FOR FOLLOW UP. NO FURTHER INFORMATION PROVIDED. QA RESULTS RECEIVED ON 02 SEPTEMBER 2016: THE COMPLAINT WAS CURRENTLY UNSUBSTANTIATED UNTIL THE SAMPLE IS RECEIVED FOR FURTHER ANALYSIS.

    Description of Event or Problem · 1

    OPEN HEART SURGERY [OPEN HEART SURGERY]. NOT GETTING BACK OF TEETH CLEAN [PRODUCT COMPLAINT]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF OPEN HEART SURGERY IN A (B)(6) FEMALE PATIENT WHO RECEIVED SENSODYNE UNKNOWN TOOTHPASTE FOR DRUG USE FOR UNKNOWN INDICATION. CO-SUSPECT PRODUCTS INCLUDED GSK TOOTHBRUSH (SENSODYNE MULTI-ACTION TOOTHBRUSH) TOOTHBRUSH FOR DRUG USE FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED SENSODYNE UNKNOWN AT AN UNKNOWN DOSE AND FREQUENCY AND SENSODYNE MULTI-ACTION TOOTHBRUSH AT AN UNKNOWN DOSE AND FREQUENCY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING SENSODYNE UNKNOWN AND SENSODYNE MULTI-ACTION TOOTHBRUSH, THE PATIENT EXPERIENCED OPEN HEART SURGERY (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND PRODUCT COMPLAINT. SENSODYNE UNKNOWN WAS CONTINUED WITH NO CHANGE. THE ACTION TAKEN WITH SENSODYNE MULTI-ACTION TOOTHBRUSH WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE OPEN HEART SURGERY WAS RECOVERED/RESOLVED AND THE OUTCOME OF THE PRODUCT COMPLAINT WAS UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE OPEN HEART SURGERY TO BE RELATED TO SENSODYNE UNKNOWN AND SENSODYNE MULTI-ACTION TOOTHBRUSH. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE PRODUCT COMPLAINT TO BE RELATED TO SENSODYNE MULTI-ACTION TOOTHBRUSH. ADDITIONAL DETAILS: REPORT RECEIVED FROM CONSUMER. THE CONSUMER REPORTED THAT SHE HAD RECENTLY UNDERGONE OPEN HEART SURGERY AND MENTIONED THAT SHE HAD BEEN USING SENSODYNE TOOTHPASTE FOR YEARS. THE CONSUMER REPORTED THAT SHE HAS A TOOTHBRUSH SHE USES FOR HER BACK TEETH. THE CONSUMER REPORTED THAT SHE FINDS THE SENSODYNE MULTI ACTION TOOTHBRUSH IS NOT GETTING THE BACK OF HER TEETH CLEAN. THE CONSUMER STATED THAT SHE DOES NOT HAVE A LOT OF CAVITIES. NO CONSENT FOR FOLLOW UP. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538865 SENSODYNE MULTI-ACTION TOOTHBRUSH TOOTHBRUSHES EFW M + C SCHIFFER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other