BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSODYNE MULTIPROTECTION TOOTHBRUSH

    MDR report key: 6274874 · Received January 24, 2017

    Report

    Report Number
    9615008-2017-00001
    Event Type
    Injury
    Date Received
    January 24, 2017
    Report Date
    February 11, 2015
    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

    REPORT # 9615008-2017-00001 IS ASSOCIATED WITH (B)(4), SENSODYNE MULTIPROTECTION TOOTHBRUSH.

    Description of Event or Problem · 1

    CHOKE [CHOKING]; PRODUCT COMPLAINT (BRISTLES DROPPING) [PRODUCT COMPLAINT]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF HEADACHE IN A FEMALE PATIENT WHO RECEIVED AMOXICILLIN TRIHYDRATE, POTASSIUM CLAVULANATE (CLAVULIN) TABLET FOR PRODUCT USED FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED CLAVULIN (ORAL) AT AN UNKNOWN DOSE AND FREQUENCY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING CLAVULIN, THE PATIENT EXPERIENCED HEADACHE, NAUSEA AND VOMITING. THE ACTION TAKEN WITH CLAVULIN WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE HEADACHE, NAUSEA AND VOMITING WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE HEADACHE, NAUSEA AND VOMITING TO BE RELATED TO CLAVULIN. ADDITIONAL INFORMATION: THE PATIENT INFORMED THAT USED THE SUSPECT PRODUCT AND PRESENTED THE DESCRIBED SYMPTOMS. FOLLOW UP INFORMATION WAS RECEIVED ON 13 JAN 2017. THIS CASE DESCRIBED THE OCCURRENCE OF CHOKING IN A (B)(6) YEAR-OLD FEMALE PATIENT. THIS CASE WAS ASSOCIATED WITH A PRODUCT COMPLAINT. CO-SUSPECT PRODUCTS INCLUDED GSK TOOTHBRUSH (SENSODYNE MULTIPROTECTION TOOTHBRUSH) TOOTHBRUSH FOR PRODUCT USED FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED SENSODYNE MULTIPROTECTION TOOTHBRUSH AT AN UNKNOWN DOSE AND FREQUENCY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING CLAVULIN AND SENSODYNE MULTIPROTECTION TOOTHBRUSH, THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), HEADACHE, NAUSEA, VOMITING, ACCIDENTAL EXPOSURE TO PRODUCT AND PRODUCT COMPLAINT. CLAVULIN WAS DISCONTINUED (DECHALLENGE WAS UNKNOWN). THE ACTION TAKEN WITH SENSODYNE MULTIPROTECTION TOOTHBRUSH WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKING, ACCIDENTAL EXPOSURE TO PRODUCT AND PRODUCT COMPLAINT WERE NOT REPORTED. THE REPORTER CONSIDERED THE CHOKING TO BE UNRELATED TO CLAVULIN. THE REPORTER CONSIDERED THE CHOKING TO BE RELATED TO SENSODYNE MULTIPROTECTION TOOTHBRUSH. THE REPORTER CONSIDERED THE HEADACHE, NAUSEA AND VOMITING TO BE UNRELATED TO SENSODYNE MULTIPROTECTION TOOTHBRUSH. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE PRODUCT COMPLAINT TO BE RELATED TO SENSODYNE MULTIPROTECTION TOOTHBRUSH. THE BRISTLES OF SENSODYNE MULTI PROTECTION WAS DROPPING AND SHE CHOKE WITH THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55523 SENSODYNE MULTIPROTECTION TOOTHBRUSH TOOTHBRUSHES EFW M + C SCHIFFER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other