BEUDAMED
    FDA Adverse Event Other Summary report: N

    SENSODYNE PRONAMEL TOOTHBRUSH GENTLE

    MDR report key: 2948124 · Received February 19, 2008

    Report

    Report Number
    9615008-2008-00004
    Event Type
    Other
    Date Received
    February 19, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 19, 2008
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    EFW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S COMMENT: GSK TOOTHBRUSHES ARE MANUFACTURED IN (B)(4). THE LOT NUMBER FOR THIS PRODUCT IS AVAILABLE AND QUALITY TESTING IS PENDING.

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURENCE OF ALMOST CHOKED IN A MALE PT WHO USED GSK TOOTHBRUSH (SENSODYNE PRONAMEL TOOTHBRUSH GENTLE) TOOTHBRUSH FOR DENTAL CLEANING. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICAL CONDITIONS INCLUDED UNSPECIFIED ALLERGIES. ON AN UNK DATE, THE PT STARTED USING A PARTICULAR GSK TOOTHBRUSH (DENTAL). ON (B)(6) 2008, THE PT ALMOST CHOKED WHEN SOME BRISTLES CAME OUT (PRODUCT COMPLAINT). THE PT WAS ABLE TO BRING THE BRISTLES UP BY COUGHING. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH THAT PARTICULAR GSK TOOTHBRUSH WAS DISCONTINUED. AT THE TIME OF REPORTING, THE EVENT WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSODYNE PRONAMEL TOOTHBRUSH GENTLE GSK TOOTHBRUSH EFW GLAXOSMITHKLINE M42264700

    Patients

    Seq Age Sex Outcome Treatment
    1 Other NO CONCURRENT MEDICATIONS