BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONICARE ESSENCE

    MDR report key: 1033414 · Received April 21, 2008

    Report

    Report Number
    3026630-2008-00001
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    February 25, 2008
    Report Date
    February 26, 2008
    Manufacturer
    PHILIPS ORAL HEALTHCARE
    Product Code
    JEQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4) PROD: YES. ON (B) (6) 2008, THE PT IS FEELING BETTER TODAY BUT SHE IS NOT EATING WELL. PER (B) (6), THIS IS EXPECTED AFTER A TRAUMATIC INCIDENT. SHE PASSED THE BRUSH HEAD LAST NIGHT. COMMENT: THIS IS ONLY THE SECOND REPORTED INCIDENT OF A SONICARE BRAND BRUSH HEAD BROKE OFF AND WAS SWALLOWED (NO CHOKING REPORTED). THE PREVIOUS REPORT WAS IN 2002. THERE IS NO INDICATION OR TREND THAT LIKE PROD WOULD REQUIRED TO BE INVESTIGATED.

    Description of Event or Problem · 1

    ON (B) (6) 2008 SPOKE WITH /(B) (6) HE IS CALLING FOR HIS WIFE WHO IS DISABLED; (SHE) HAS MANY MEDICAL PROBLEMS BUT LIVES AT HOME. SHE IS CARED FOR AT HOME BY HER HUSBAND AND NURSE CARETAKER. (B) (6) BRUSHES THE PT'S TEETH 1 TO 2 TIMES PT DAY. ONCE A DAY, HE BRUSHES VERY WELL FOR 2 PLUS MINUTES. HE NEEDS TO BRUSH HER TEETH FOR HER. LAST NIGHT SHE BIT OFF THE BRUSH HEAD AND LEFT A JAGGED PC (PIECE) (ONE ROW OF BRISTLES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SONICARE ESSENCE TOOTHBRUSH, POWERED JEQ PHILIPS ORAL HEALTHCARE 4235 010 04751 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other