BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSODYNE PRONAMEL TOOTHBRUSH

    MDR report key: 6504557 · Received April 19, 2017

    Report

    Report Number
    9615008-2017-00005
    Event Type
    Injury
    Date Received
    April 19, 2017
    Report Date
    April 11, 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
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS ASSOCIATED WITH ARGUS (B)(4), SENSODYNE PRONAMEL TOOTHBRUSH.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS ASSOCIATED WITH ARGUS (B)(4), SENSODYNE PRONAMEL TOOTHBRUSH.

    Description of Event or Problem · 1

    CHOKING. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF CHOKING IN A FEMALE PATIENT WHO RECEIVED GSK TOOTHBRUSH (SENSODYNE PRONAMEL TOOTHBRUSH) TOOTHBRUSH FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED SENSODYNE PRONAMEL TOOTHBRUSH. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING SENSODYNE PRONAMEL TOOTHBRUSH, THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND PRODUCT COMPLAINT. THE ACTION TAKEN WITH SENSODYNE PRONAMEL TOOTHBRUSH WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKING AND PRODUCT COMPLAINT WERE NOT REPORTED. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE CHOKING TO BE RELATED TO SENSODYNE PRONAMEL TOOTHBRUSH. ADDITIONAL DETAILS: THE PATIENT USED THE TOOTHBRUSH FOR THE FIRST TIME, AND AFTER NEARLY CHOKING ON IT, NOTICED THAT THE BRISTLES WERE COMING OUT OF THE BRUSH.

    Description of Event or Problem · 1

    CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF CHOKING IN A FEMALE PATIENT WHO RECEIVED GSK TOOTHBRUSH (SENSODYNE PRONAMEL TOOTHBRUSH) TOOTHBRUSH FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED SENSODYNE PRONAMEL TOOTHBRUSH. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING SENSODYNE PRONAMEL TOOTHBRUSH, THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND PRODUCT COMPLAINT. THE ACTION TAKEN WITH SENSODYNE PRONAMEL TOOTHBRUSH WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKING AND PRODUCT COMPLAINT WERE NOT REPORTED. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE CHOKING TO BE RELATED TO SENSODYNE PRONAMEL TOOTHBRUSH. ADDITIONAL DETAILS: THE PATIENT USED THE TOOTHBRUSH FOR THE FIRST TIME, AND AFTER NEARLY CHOKING ON IT, NOTICED THAT THE BRISTLES WERE COMING OUT OF THE BRUSH. FOLLOW UP INFORMATION RECEIVED ON 17-APR-2017: BATCH NUMBER PROVIDED: 63431.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286989 SENSODYNE PRONAMEL TOOTHBRUSH TOOTHBRUSHES EFW M + C SCHIFFER GMBH 63431

    Patients

    Seq Age Sex Outcome Treatment
    1 Other