BEUDAMED
    FDA Adverse Event Other Summary report: N

    PARODONTAX TOOTHBRUSH

    MDR report key: 5161443 · Received October 16, 2015

    Report

    Report Number
    9615008-2015-00008
    Event Type
    Other
    Date Received
    October 16, 2015
    Report Date
    September 23, 2015
    Manufacturer
    M + C SCHIFFER GMBH
    Product Code
    EFW
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    9615008-2015-00008 IS ASSOCIATED WITH ARGUS CASE (B)(4) PARODONTAX TOOTHBRUSH. PARODONTAX TOOTHBRUSH IS MARKETED AS SENSODYNE PRONAMEL TOOTHBRUSH IN THE US.

    Description of Event or Problem · 1

    CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA INTERACTIVE DIGITAL MEDIA AND DESCRIBED THE OCCURRENCE OF CHOKING IN A FEMALE PATIENT WHO RECEIVED GSK TOOTHBRUSH (PARODONTAX TOOTHBRUSH) TOOTHBRUSH FOR DENTAL CLEANING. ON AN UNKNOWN DATE, THE PATIENT STARTED PARODONTAX TOOTHBRUSH AT AN UNKNOWN DOSE AND FREQUENCY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING PARODONTAX TOOTHBRUSH, THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), FOREIGN BODY IN MOUTH AND PRODUCT COMPLAINT. THE ACTION TAKEN WITH PARODONTAX TOOTHBRUSH WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKING, FOREIGN BODY IN MOUTH AND PRODUCT COMPLAINT WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE CHOKING AND FOREIGN BODY IN MOUTH TO BE RELATED TO PARODONTAX TOOTHBRUSH. ADDITIONAL INFORMATION THIS CONSUMER REPORT HAD BEEN RECEIVED AS COMPLAINT VIA E-MAIL (IDM UNKNOWN). THE CONSUMER COMPLAINED ON QUALITY OF PARODONTAX TOOTHBRUSH SHE HAD BOUGHT IN THE MARKET. DURING TEETH BRUSHING THE CONSUMER EXPERIENCED BRISTLES DROPPING OUT OF THE TOOTHBRUSH AND REMAINED IN THE MOUTH. DURING HER LAST TEETH BRUSHING THE CONSUMER ALMOST CHOKED BY THE BRISTLE, WHICH REMAINED IN HER NECK. IN (B)(4) PARODONTAX TOOTHBRUSH WAS NOT REGISTERED AS DRUG, MEDICAL DEVICE OR COSMETICS. IT WAS OTHER ASSORTMENT. FOLLOW UP RECEIVED 28 SEPTEMBER 2015: PARODONTAX TOOTHBRUSH WAS STARTED IN (B)(6) 2015. PARODONTAX TOOTHBRUSH WAS WITHDRAWN ON AN UNKNOWN DATE AFTER THE EVENT. FOLLOW UP RECEIVED 7 MARCH 2016: THE CONSUMER INFORMED ABOUT THE REPETITION OF NEGATIVE EXPERIENCE WITH 3-PACK OF PARODONTAX TOOTHBRUSH. SHE REPEATEDLY BOUGHT THE 3 PACK AT THE DIFFERENT PART OF (B)(4) AND THE PROBLEM, LOSING OF BRISTLES FROM ONE OF THE TOOTHBRUSH. THE CONSUMER POINTED OUT THE PROBLEM OCCURRED AGAIN WITH THE YELLOW VERSION OF TOOTHBRUSHES IN THE FIRST CASE AND ALSO IN THIS CASE.

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER VIA INTERACTIVE DIGITAL MEDIA AND DESCRIBED THE OCCURRENCE OF CHOKING IN A FEMALE PATIENT WHO RECEIVED GSK TOOTHBRUSH (PARODONTAX TOOTHBRUSH) TOOTHBRUSH FOR DENTAL CLEANING. ON AN UNKNOWN DATE, THE PATIENT STARTED PARODONTAX TOOTHBRUSH AT AN UNKNOWN DOSE AND FREQUENCY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING PARODONTAX TOOTHBRUSH, CONTINUED IN ADDITIONAL INFO SECTION THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), FOREIGN BODY IN MOUTH AND PRODUCT COMPLAINT. THE ACTION TAKEN WITH PARODONTAX TOOTHBRUSH WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKING, FOREIGN BODY IN MOUTH AND PRODUCT COMPLAINT WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE CHOKING AND FOREIGN BODY IN MOUTH TO BE RELATED TO PARODONTAX TOOTHBRUSH. THIS CONSUMER REPORT HAD BEEN RECEIVED AS COMPLAINT VIA E-MAIL (IDM UNKNOWN). THE CONSUMER COMPLAINED ON QUALITY OF PARODONTAX TOOTHBRUSH SHE HAD BOUGHT IN THE MARKET. DURING TEETH BRUSHING THE CONSUMER EXPERIENCED BRISTLES DROPPING OUT OF THE TOOTHBRUSH AND REMAINED IN THE MOUTH. DURING HER LAST TEETH BRUSHING THE CONSUMER ALMOST CHOKED BY THE BRISTLE, WHICH REMAINED IN HER NECK. IN SLOVAKIA PARODONTAX TOOTHBRUSH WAS NOT REGISTERED AS DRUG, MEDICAL DEVICE OR COSMETICS. IT WAS OTHER ASSORTMENT. FOLLOW UP RECEIVED 28 SEPTEMBER 2015: PARODONTAX TOOTHBRUSH WAS STARTED IN (B)(6) 2015. PARODONTAX TOOTHBRUSH WAS WITHDRAWN ON AN UNKNOWN DATE AFTER HE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687375 PARODONTAX TOOTHBRUSH TOOTHBRUSHES EFW M + C SCHIFFER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other