BEUDAMED
    FDA Adverse Event Other Summary report: N

    AQUAFRESH TOOTHBRUSH

    MDR report key: 2823657 · Received October 31, 2012

    Report

    Report Number
    9615008-2012-00003
    Event Type
    Other
    Date Received
    October 31, 2012
    Report Date
    October 26, 2012
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    EFW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF CHOKING IN A FEMALE PATIENT WHO RECEIVED GSK TOOTHBRUSH (AQUAFRESH TOOTHBRUSH) FOR AN UNKNOWN DRUG INDICATION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNKNOWN DATE, THE PATIENT STARTED GSK TOOTHBRUSH. AT AN UNKNOWN TIME AFTER STARTING GSK TOOTHBRUSH, THE PATIENT THOUGHT SHE WAS GOING TO CHOKE TO DEATH. THE PATIENT WAS COUGHING AND SPAT OUT GREEN BRISTLES. THE PATIENT ALSO EXPERIENCED VOMITING. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS UNKNOWN. THE MANUFACTURER'S REPORT NUMBER FOR THIS CASE IS 9615008-2012-00003. AQUAFRESH TOOTHBRUSH IS MANUFACTURED IN (B)(4), AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT IS AVAILABLE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUAFRESH TOOTHBRUSH GSK TOOTHBRUSH EFW GLAXOSMITHKLINE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other