BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUAFRESH KIDS TOOTHBRUSH

    MDR report key: 5466850 · Received February 29, 2016

    Report

    Report Number
    9615008-2016-00003
    Event Type
    Injury
    Date Received
    February 29, 2016
    Report Date
    February 16, 2016
    Manufacturer
    M + C SCHIFFER GMBH
    Product Code
    EFW
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    9615008-2016-00003 IS ASSOCIATED WITH ARGUS CASE (B)(4) AQUAFRESH KIDS TOOTHBRUSH.

    Description of Event or Problem · 1

    CHOKE [CHOKING], COUGH [COUGH], THROW UP [VOMITING], CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA INTERACTIVE DIGITAL MEDIA AND DESCRIBED THE OCCURRENCE OF CHOKING IN A (B)(6) FEMALE PATIENT WHO RECEIVED GSK TOOTHBRUSH (AQUAFRESH KIDS TOOTHBRUSH) TOOTHBRUSH (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR PRODUCT USED FOR UNKNOWN INDICATION. THIS CASE WAS ASSOCIATED WITH A PRODUCT COMPLAINT. IN (B)(6) 2016, THE PATIENT STARTED AQUAFRESH KIDS TOOTHBRUSH AT AN UNKNOWN DOSE AND FREQUENCY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING AQUAFRESH KIDS TOOTHBRUSH, THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), COUGH, VOMITING AND PRODUCT COMPLAINT. THE ACTION TAKEN WITH AQUAFRESH KIDS TOOTHBRUSH WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKING, COUGH AND VOMITING WERE RECOVERED/RESOLVED AND THE OUTCOME OF THE PRODUCT COMPLAINT WAS UNKNOWN. THE REPORTER CONSIDERED THE CHOKING, COUGH AND VOMITING TO BE RELATED TO AQUAFRESH KIDS TOOTHBRUSH. ADDITIONAL INFORMATION, THE ADVERSE EVENT WAS FOUND BY (B)(6) ON (B)(6) 2016. THE CONSUMER POSTED THAT OUR (B)(6) DAUGHTER'S TOOTH BRUSH JUST DECIDED TO FALL APART IN HER MOUTH CAUSING HER TO CHOKE, COUGH AND EVENTUALLY THROW UP. SHE WAS FINE, BUT IT WASN'T VERY NICE FOR HER TO PICK BRISTLES FROM HER MOUTH BEFORE BED. THE TOOTHBRUSH WAS ONLY 2 WEEKS OLD. IT WAS TERRIBLE BUILD QUALITY FROM A SUPPOSEDLY TOP SUPPLIER OF TOOTH AND MOUTH CARE PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124893 AQUAFRESH KIDS TOOTHBRUSH TOOTHBRUSHES EFW M + C SCHIFFER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Other