BEUDAMED
    FDA Adverse Event Other Summary report: N

    SONICARE

    MDR report key: 376820 · Received February 8, 2002

    Report

    Report Number
    3026630-2002-00001
    Event Type
    Other
    Date Received
    February 8, 2002
    Date of Event
    January 11, 2002
    Report Date
    February 8, 2002
    Manufacturer
    PHILIPS ORAL HEALTHCARE
    Product Code
    JEQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CAREGIVER OF A PT WAS BRUSHING THE TEETH OF THE PT WHEN A PORTION OF THE SPLASH GUARD BROKE OFF. THE CAREGIVER ATTEMPTED TO RETRIEVE IT BUT THE INDIVIDUAL SWALLOWED IT. THE INDIVIDUAL WAS THEN TAKEN TO THE ER FOR X-RAYS AND WAS SENT BACK TO THE CARE CENTER FOR OBSERVATION. PT WAS REPORTED AS "OK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SONICARE ELECTRIC TOOTHBRUSH REPLACEABLE BRUSHHEAD JEQ PHILIPS ORAL HEALTHCARE 3035 910048

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other