BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONICARE

    MDR report key: 212815 · Received February 18, 1999

    Report

    Report Number
    MW4002455
    Event Type
    Injury
    Date Received
    February 18, 1999
    Report Date
    January 5, 1999
    Manufacturer
    OPTIVA CORP.
    Product Code
    JEQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AN ELECTRONIC TOOTHBRUSH FRACTURED COMPLAINANT'S TOOTH THEN A MONTH LATER, HER HUSBAND'S TOOTH WAS ALSO FRACTURED AFTER USING THE SAME DEVICE. SHE SUSPECTED TOOTHBRUSH AFTER HER HUSBAND'S TOOTH FRACTURED. MFR WAS CONTACTED AND PRODUCT RETURNED ON 1/4/99. MFR PROMISED REIMBURSEMENT, CLAIMING PRODUCT INTENDED ONLY FOR HEALTHY TEETH. HER "TOOTH IN GOOD CONDITION", VISITED DENTIST IN SPRING '98. THE PRODUCT HAS WARNING "TO AVOID POSSIBLE DAMAGE OR INJURY TO TEETH BE SURE THAT ONLY BRISTLE OF BRUSH HEAD TOUCHES YOUR TEETH AND GUMS." COMPLAINANT INDICATES THE HEAD OF TOOTHBRUSH IS WAY TOO LARGE, AND AS SUCH, SHE FINDS IT DIFFICULT TO PREVENT INJURY. THE COMPLAINANT IS A GERIATRIC NURSE AND SHE WOULD LIKE TO SEE A WARNING FOR ELDERLY PEOPLE WHO DO NOT HAVE CONTROL OF HAND REFLEXES OR WHO MAY HAVE BAD COORDINATION.

    Description of Event or Problem · 2

    AN ELECTRONIC TOOTHBRUSH FRACTURED COMPLAINANT'S TOOTH THEN A MONTH LATER, HER HUSBAND'S TOOTH WAS ALSO FRACTURED AFTER USING THE SAME DEVICE. SHE SUSPECTED TOOTHBRUSH AFTER HER HUSBAND'S TOOTH FRACTURED. MFR WAS CONTACTED AND PRODUCT RETURNED ON 1/4/99. MFR PROMISED REIMBURSEMENT, CLAIMING PRODUCT INTENDED ONLY FOR HEALTHY TEETH. HER "TOOTH IN GOOD CONDITION", VISITED DENTIST IN SPRING '98. THE PRODUCT HAS A WARNING "TO AVOID POSSIBLE DAMAGE OR INJURY TO TEETH BE SURE THAT ONLY BRISTLE OR BRUSH HEAD TOUCHES YOUR TEETH AND GUMS". COMPLAINANT INDICATES THE HEAD OF TOOTHBRUSH IS WAY TOO LARGE, AND AS SUCH, SHE FINDS IT DIFFICULT TO PREVENT INJURY. THE COMPLAINANT IS A GERIATRIC NURSE AND SHE WOULD LIKE TO SEE A WARNING FOR ELDERLY PEOPLE WHO DO NOT HAVE CONTROL OF HAND REFLEXES OR WHO MAY HAVE BAD COORDINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SONICARE ELECTRONIC TOOTHBRUSH/BASE HOLDER JEQ OPTIVA CORP. PS1 804067L, 804027

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other
    2 NO INFO Other