BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSODYNE TOOTHBRUSH

    MDR report key: 6306973 · Received February 7, 2017

    Report

    Report Number
    9615008-2017-00002
    Event Type
    Injury
    Date Received
    February 7, 2017
    Report Date
    January 27, 2017
    Manufacturer
    M + C SCHIFFER GMBH
    Product Code
    EFW
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ASSOCIATED WITH ARGUS CASE FR2017GSK013879, SENSODYNE TOOTHBRUSH.

    Description of Event or Problem · 1

    CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA OTHER AND DESCRIBED THE OCCURRENCE OF HEMORRHAGE IN A FEMALE PATIENT WHO RECEIVED GSK TOOTHBRUSH (SENSODYNE TOOTHBRUSH) TOOTHBRUSH FOR DRUG USE FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED SENSODYNE TOOTHBRUSH. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING SENSODYNE TOOTHBRUSH, THE PATIENT EXPERIENCED HEMORRHAGE (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT). THE ACTION TAKEN WITH SENSODYNE TOOTHBRUSH WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE HEMORRHAGE WAS UNKNOWN. THE REPORTER CONSIDERED THE HEMORRHAGE TO BE RELATED TO SENSODYNE TOOTHBRUSH. FOLLOW UP INFORMATION RECEIVED 27 FEB 2017. FOLLOWING INTERNAL REVIEW IT WAS DETERMINED THE INITIAL RECEIPT DATE WAS 27-FEB-2017. THE CASE WAS ORIGINALLY PROCESSED WITH FOLLOW UP RECEIPT DATES TICKED, HENCE PROVIDING A LATER CLOCK START DATE. THE FOLLOW UP RECEIPT DATE 31-JAN-2017, WAS ADDED IN ERROR BY THE LOC.

    Description of Event or Problem · 1

    BLEEDING [HEMORRHAGE]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA OTHER AND DESCRIBED THE OCCURRENCE OF HEMORRHAGE IN A FEMALE PATIENT WHO RECEIVED GSK TOOTHBRUSH (SENSODYNE TOOTHBRUSH) TOOTHBRUSH FOR DRUG USE FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED SENSODYNE TOOTHBRUSH. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING SENSODYNE TOOTHBRUSH, THE PATIENT EXPERIENCED HEMORRHAGE (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT). THE ACTION TAKEN WITH SENSODYNE TOOTHBRUSH WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE HEMORRHAGE WAS UNKNOWN. THE REPORTER CONSIDERED THE HEMORRHAGE TO BE RELATED TO SENSODYNE TOOTHBRUSH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89376 SENSODYNE TOOTHBRUSH TOOTHBRUSHES EFW M + C SCHIFFER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other