BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUAFRESH FLEX TOOTHBRUSH

    MDR report key: 6173973 · Received December 14, 2016

    Report

    Report Number
    9615008-2016-00013
    Event Type
    Injury
    Date Received
    December 14, 2016
    Report Date
    December 11, 2016
    Manufacturer
    M + C SCHIFFER GMBH
    Product Code
    EFW
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS ASSOCIATED WITH ARGUS CASE (B)(4), AQUAFRESH FLEX TOOTHBRUSH.

    Description of Event or Problem · 1

    A (B)(6) WHILST BRUSHING HER TEETH HAS GOT A MOUTHFUL OF BRISTLES [ACCIDENTAL DEVICE INGESTION BY A CHILD]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA INTERACTIVE DIGITAL MEDIA AND DESCRIBED THE OCCURRENCE OF ACCIDENTAL DEVICE INGESTION BY A CHILD IN A (B)(6) FEMALE PATIENT WHO RECEIVED GSK TOOTHBRUSH (AQUAFRESH FLEX TOOTHBRUSH) TOOTHBRUSH (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR DRUG USE FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED AQUAFRESH FLEX TOOTHBRUSH. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING AQUAFRESH FLEX TOOTHBRUSH, THE PATIENT EXPERIENCED ACCIDENTAL DEVICE INGESTION BY A CHILD (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT AND OTHER: GSK MEDICALLY SIGNIFICANT) AND ACCIDENTAL DRUG INTAKE BY CHILD. ON AN UNKNOWN DATE, THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION BY A CHILD AND ACCIDENTAL DRUG INTAKE BY CHILD WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION BY A CHILD TO BE RELATED TO AQUAFRESH FLEX TOOTHBRUSH. ADDITIONAL DETAILS, THIS ADVERSE EVENT INFORMATION WAS RECEIVED VIA SOCIAL MEDIA FROM (B)(6) ON 11 DECEMBER 2016. THE CONSUMER POSTED THAT, RECENTLY SHE BOUGHT A TOOTHBRUSH IN THE 0-2 AGE RANGE AND HER (B)(6) WHILST BRUSHING HER TEETH HAD GOT A MOUTHFUL OF BRISTLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824848 AQUAFRESH FLEX TOOTHBRUSH TOOTHBRUSHES EFW M + C SCHIFFER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 17 MO Other