BEUDAMED
    FDA Adverse Event Other Summary report: N

    AQUAFRESH GEL-FLEX TOOTHBRUSH SOFT

    MDR report key: 1002954 · Received February 5, 2008

    Report

    Report Number
    9615008-2008-00001
    Event Type
    Other
    Date Received
    February 5, 2008
    Report Date
    February 5, 2008
    Manufacturer
    GLAXOSMITHKLINE RTP
    Product Code
    EFW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF -ALMOST CHOKED- IN A MALE PT WHO RECEIVED GSK TOOTHBRUSH (AQUAFRESH GEL-FLEX TOOTHBRUSH SOFT) TOOTHBRUSH FOR AN UNK DRUG INDICATION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, THE PT STARTED GSK TOOTHBRUSH (DENTAL). AT AN UNK TIME AFTER STARTING GSK TOOTHBRUSH, THE BRISTLES ON THE TOOTHBRUSH BECAME LOOSE (PHARMACEUTICAL PRODUCT COMPLAINT) AND THE PT ALMOST CHOKED. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH GSK TOOTHBRUSH WAS DISCONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE RESOLVED. MFR'S COMMENT: THE MFR REPORT NUMBER FOR THIS CASE IS 9615008-2008-00001. AQUAFRESH GEL FLEX SOFT TOOTHBRUSH IS MANUFACTURED IN OTHER COUNTRY. THE LOT NUMBER FOR THIS PRODUCT IS AVAILABLE AND QUALITY TESTING IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUAFRESH GEL-FLEX TOOTHBRUSH SOFT TOOTHBRUSH EFW GLAXOSMITHKLINE RTP 571455825

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other