BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSODYNE COMPLETE TOOTHBRUSH EXTRA SOFT

    MDR report key: 6816715 · Received August 24, 2017

    Report

    Report Number
    9615008-2017-00011
    Event Type
    Injury
    Date Received
    August 24, 2017
    Report Date
    August 18, 2017
    Manufacturer
    M + C SCHIFFER GMBH
    Product Code
    EFW
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    9615008-2017-00011 IS ASSOCIATED WITH ARGUS CASE (B)(4), SENSODYNE COMPLETE TOOTHBRUSH EXTRA SOFT. SENSODYNE COMPLETE TOOTHBRUSH EXTRA SOFT IS MARKETED AS SENSODYNE GENTLE EXTRA SOFT TOOTHBRUSH IN THE US. QA CONCLUSION: PRODUCT COMPLAINT IS UNSUBSTANTIATED. COVERED IN COMPLAINT INVESTIGATION MANUAL (CIM).

    Additional Manufacturer Narrative · 1

    THIS REPORT IS ASSOCIATED WITH ARGUS (B)(4), SENSODYNE COMPLETE TOOTHBRUSH EXTRA SOFT. SENSODYNE COMPLETE TOOTHBRUSH EXTRA SOFT IS MARKETED AS SENSODYNE GENTLE EXTRA SOFT TOOTHBRUSH IN THE US.

    Description of Event or Problem · 1

    CHOKING SENSATION [CHOKING SENSATION]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF CHOKING IN A PATIENT WHO RECEIVED GSK TOOTHBRUSH (SENSODYNE COMPLETE TOOTHBRUSH EXTRA SOFT) TOOTHBRUSH FOR PRODUCT USED FOR UNKNOWN INDICATION. THIS CASE WAS ASSOCIATED WITH PRODUCT COMPLAINT. ON AN UNKNOWN DATE, THE PATIENT STARTED SENSODYNE COMPLETE TOOTHBRUSH EXTRA SOFT AT AN UNKNOWN DOSE AND FREQUENCY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING SENSODYNE COMPLETE TOOTHBRUSH EXTRA SOFT, THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND PRODUCT COMPLAINT. THE ACTION TAKEN WITH SENSODYNE COMPLETE TOOTHBRUSH EXTRA SOFT WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKING WAS NOT REPORTED AND THE OUTCOME OF THE PRODUCT COMPLAINT WAS UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE CHOKING TO BE RELATED TO SENSODYNE COMPLETE TOOTHBRUSH EXTRA SOFT. ADDITIONAL DETAILS: THE CONSUMER REPORTED THAT HE BOUGHT TWO EXTRA SOFT SENSODYNE TOOTHBRUSHES, BUT THE BRISTLES WERE COMING OUT DURING USE, WHICH MAKES HIM CHOKE. HE CLAIMED TO HAD USED THE BRUSH ONLY 3 TIMES. FOLLOW UP WAS RECEIVED ON 18 AUG 2017. DURING THE INITIAL REPORT, THE EVENTS WAS DESCRIBED ERRONEOUSLY .THE CORRECT NAME OF EVENT WAS CHOCKING SENSATION, AND NOT CHOCKING AS DESCRIBED BEFORE. THE EVENT CHOKING WAS CORRECTED TO CHOCKING SENSATION. FOLLOW UP WAS RECEIVED FROM QUALITY ASSURANCE DEPARTMENT ON 21 AUG 2017. QUALITY ASSURANCE ANALYSIS REVEALED THE COMPLAINT TO BE UNSUBSTANTIATED.

    Description of Event or Problem · 1

    CHOCKING [CHOKING]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF CHOKING IN A PATIENT WHO RECEIVED GSK TOOTHBRUSH (SENSODYNE COMPLETE TOOTHBRUSH EXTRA SOFT) TOOTHBRUSH FOR PRODUCT USED FOR UNKNOWN INDICATION. THIS CASE WAS ASSOCIATED WITH PRODUCT COMPLAINT. ON AN UNKNOWN DATE, THE PATIENT STARTED SENSODYNE COMPLETE TOOTHBRUSH EXTRA SOFT AT AN UNKNOWN DOSE AND FREQUENCY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING SENSODYNE COMPLETE TOOTHBRUSH EXTRA SOFT, THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND PRODUCT COMPLAINT. THE ACTION TAKEN WITH SENSODYNE COMPLETE TOOTHBRUSH EXTRA SOFT WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKING WAS NOT REPORTED AND THE OUTCOME OF THE PRODUCT COMPLAINT WAS UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE CHOKING TO BE RELATED TO SENSODYNE COMPLETE TOOTHBRUSH EXTRA SOFT. ADDITIONAL DETAILS, THE CONSUMER REPORTED THAT HE BOUGHT TWO EXTRA SOFT SENSODYNE TOOTHBRUSHES, BUT THE BRISTLES WERE COMING OUT DURING USE, WHICH MAKES HIM CHOKE. HE CLAIMED TO HAD USED THE BRUSH ONLY 3 TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597222 SENSODYNE COMPLETE TOOTHBRUSH EXTRA SOFT TOOTHBRUSHES EFW M + C SCHIFFER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other