BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DR BEST X- ZWISCHENZAHN TOOTHBRUSH

    MDR report key: 5974028 · Received September 23, 2016

    Report

    Report Number
    9615008-2016-00011
    Event Type
    Injury
    Date Received
    September 23, 2016
    Report Date
    September 7, 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
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 9615008-2016-00011IS ASSOCIATED WITH ARGUS CASE (B)(4), DR BEST ZWISCHENZAHN TOOTHBRUSH. DR BEST ZWISCHENZAHN TOOTHBRUSH IS MARKETED AS SENSODYNE PRONAMEL TOOTHBRUSH IN THE US.

    Additional Manufacturer Narrative · 1

    THE REPORT # 9615008-2016-00011 IS ASSOCIATED WITH (B)(4), DR BEST ZWISCHENZAHN TOOTHBRUSH. DR BEST ZWISCHENZAHN TOOTHBRUSH IS MARKETED AS SENSODYNE PRONAMEL TOOTHBRUSH IN THE U.S.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS ASSOCIATED WITH ARGUS CASE (B)(4), DR BEST X- ZWISCHENZAHN TOOTHBRUSH. DR BEST X- ZWISCHENZAHN TOOTHBRUSH IS MARKETED AS SENSODYNE PRONAMEL TOOTHBRUSH IN THE US.

    Description of Event or Problem · 1

    NEARLY CHOKED BY A BRISTLE [CHOKING]. SEVERE VOMITING [VOMITING]. BRISTLES STUCK IN THROAT [FOREIGN BODY IN PHARYNX]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF CHOKING IN A MALE PATIENT WHO RECEIVED GSK TOOTHBRUSH (DR BEST ZWISCHENZAHN) TOOTHBRUSH FOR PRODUCT USED FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED DR BEST ZWISCHENZAHN AT AN UNKNOWN DOSE AND FREQUENCY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING DR BEST ZWISCHENZAHN, THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), VOMITING, FOREIGN BODY IN PHARYNX AND PHARMACEUTICAL PRODUCT COMPLAINT. THE ACTION TAKEN WITH DR BEST ZWISCHENZAHN WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKING AND FOREIGN BODY IN PHARYNX WERE RECOVERED/RESOLVED AND THE OUTCOME OF THE VOMITING AND PHARMACEUTICAL PRODUCT COMPLAINT WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE CHOKING, VOMITING AND FOREIGN BODY IN PHARYNX TO BE RELATED TO DR BEST ZWISCHENZAHN. ADDITIONAL DETAILS: THE PATIENT USED DR BEST ZWISCHENZAHN FOR 2 WEEKS AND HISTORICAL DRUG INCLUDED DR. BEST TOOTHBRUSHES (USED SINCE YEARS). THE TREATMENT DRUG INCLUDED DRINKING FLUID.

    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 MALE PATIENT WHO RECEIVED GSK TOOTHBRUSH (DR BEST ZWISCHENZAHN) TOOTHBRUSH FOR PRODUCT USED FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED DR BEST ZWISCHENZAHN AT AN UNKNOWN DOSE AND FREQUENCY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING DR BEST ZWISCHENZAHN, THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), VOMITING, FOREIGN BODY IN PHARYNX AND PHARMACEUTICAL PRODUCT COMPLAINT. THE ACTION TAKEN WITH DR BEST ZWISCHENZAHN WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKING AND FOREIGN BODY IN PHARYNX WERE RECOVERED/RESOLVED AND THE OUTCOME OF THE VOMITING AND PHARMACEUTICAL PRODUCT COMPLAINT WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE CHOKING, VOMITING AND FOREIGN BODY IN PHARYNX TO BE RELATED TO DR BEST ZWISCHENZAHN. ADDITIONAL DETAILS, THE PATIENT USED DR BEST ZWISCHENZAHN FOR 2 WEEKS AND HISTORICAL DRUG INCLUDED DR. BEST TOOTHBRUSHES (USED SINCE YEARS). THE TREATMENT DRUG INCLUDED DRINKING FLUID. FOLLOW UP RECEIVED ON 28 SEP 2016. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED DR. BEST TOOTHBRUSHES (USED SINCE YEARS). ON (B)(6) 2016, THE PATIENT STARTED DR BEST ZWISCHENZAHN. DR BEST ZWISCHENZAHN WAS DISCONTINUED ON (B)(6) 2016 (DECHALLENGE WAS POSITIVE). THE RED BRISTLES DISSOLVED AND STUCK IN THE THROAT. ON AN UNKNOWN DATE, THE OUTCOME OF THE VOMITING WERE RECOVERED/RESOLVED. THE REPORTER CAUSALITY ASSESSMENT WAS UNKNOWN FOR ALL EVENTS.

    Description of Event or Problem · 1

    NEARLY CHOKED BY A BRISTLE. SEVERE VOMITING. BRISTLES STUCK IN THROAT. COULD NOT BREATHE. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF CHOKING IN A MALE PATIENT WHO RECEIVED GSK TOOTHBRUSH (DR BEST ZWISCHENZAHN) TOOTHBRUSH FOR PRODUCT USED FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED DR BEST ZWISCHENZAHN AT AN UNKNOWN DOSE AND FREQUENCY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING DR BEST ZWISCHENZAHN, THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), VOMITING, FOREIGN BODY IN PHARYNX AND PHARMACEUTICAL PRODUCT COMPLAINT. THE ACTION TAKEN WITH DR BEST ZWISCHENZAHN WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKING AND FOREIGN BODY IN PHARYNX WERE RECOVERED/RESOLVED AND THE OUTCOME OF THE VOMITING AND PHARMACEUTICAL PRODUCT COMPLAINT WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE CHOKING, VOMITING AND FOREIGN BODY IN PHARYNX TO BE RELATED TO DR BEST ZWISCHENZAHN. ADDITIONAL DETAILS, THE PATIENT USED DR BEST ZWISCHENZAHN FOR 2 WEEKS AND HISTORICAL DRUG INCLUDED DR. BEST TOOTHBRUSHES (USED SINCE YEARS). THE TREATMENT DRUG INCLUDED DRINKING FLUID. FOLLOW UP RECEIVED ON 28 SEP 2016. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED DR. BEST TOOTHBRUSHES (USED SINCE YEARS). ON (B)(6) 2016, THE PATIENT STARTED DR BEST ZWISCHENZAHN. DR BEST ZWISCHENZAHN WAS DISCONTINUED ON (B)(6) 2016 (DECHALLENGE WAS POSITIVE). THE RED BRISTLES DISSOLVED AND STUCK IN THE THROAT. ON AN UNKNOWN DATE, THE OUTCOME OF THE VOMITING WERE RECOVERED/RESOLVED. THE REPORTER CAUSALITY ASSESSMENT WAS UNKNOWN FOR ALL EVENTS. FOLLOW-UP INFORMATION WAS RECEIVED ON 22 DEC 2016. THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF CHOKING IN A (B)(6) MALE PATIENT WHO RECEIVED GSK TOOTHBRUSH (DR BEST X- ZWISCHENZAHN TOOTHBRUSH) TOOTHBRUSH FOR PRODUCT USED FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING DR BEST X- ZWISCHENZAHN TOOTHBRUSH, THE PATIENT EXPERIENCED DIFFICULTY BREATHING AND PHARMACEUTICAL PRODUCT COMPLAINT. THE ACTION TAKEN WITH DR BEST X- ZWISCHENZAHN TOOTHBRUSH WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKING, VOMITING AND FOREIGN BODY IN PHARYNX WERE RECOVERED/RESOLVED AND THE OUTCOME OF THE DIFFICULTY BREATHING AND PHARMACEUTICAL PRODUCT COMPLAINT WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE DIFFICULTY BREATHING TO BE RELATED TO DR BEST X- ZWISCHENZAHN TOOTHBRUSH. THE CONSUMER REPORTED, THAT HE HAS USED DR.BEST LIMITED EDITION TOOTHBRUSH WHICH WAS IDENTIFIED AS DR. BEST X- ZWISCHENZAHN TOOTHBRUSH. CALLER ALSO MENTIONED THAT THE CONSUMER EXPERIENCED VOMITING, COULD NOT BREATHE AND THE BRISTLES STUCK IN THE BACK OF THE THROAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623914 DR BEST X- ZWISCHENZAHN TOOTHBRUSH TOOTHBRUSHES EFW M + C SCHIFFER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other