BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERSONALIZED TOOTHBRUSH

    MDR report key: 330409 · Received April 26, 2001

    Report

    Report Number
    MW1021718
    Event Type
    Malfunction
    Date Received
    April 26, 2001
    Date of Event
    April 15, 2001
    Report Date
    April 23, 2001
    Manufacturer
    NLD
    Product Code
    JEQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    NO INJURIES, THE RPTR NOTICED THE PROBLEM BEFORE INJURY OCCURRED. RPTR PURCHASED A "PERSONALIZED TOOTHBRUSH FROM THE RPTR'S LOCAL MEIJER'S STORE. THE TOOTHBRUSH PLASTIC FRACTURED ON THE SIDE DURING NORMAL BRUSHING GIVING OFF 3 SHARDS OF PLASTIC WHICH RPTR NOTICED IN THEIR MOUTH BEFORE INJURY OCCURRED. RPTR REPORTED THIS INCIDENT TO AN AGENCY WHO REFERRED THEM TO THIS AGENCY AS IT WAS CONSIDERED A COSMETIC PRODUCT REGULATED BY FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19238 PERSONALIZED TOOTHBRUSH TOOTHBRUSH JEQ NLD "MARK" PERSONALIZED TOOTHBRUSH NONE VISIBLE

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR