BEUDAMED
    FDA Adverse Event Summary report: N

    COLGATE MOTION ADULT TOOTHBRUSH

    MDR report key: 2093052 · Received May 3, 2011

    Report

    Report Number
    3005607635-2011-00001
    Date Received
    May 3, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 5, 2011
    Manufacturer
    HI-P (XIAMEN) PRECISION PLASTIC MANUFACTURING CO.
    Product Code
    JEQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    INITIAL INFORMATION WAS REC'D ON (B)(6) 2011 FROM A FEMALE CONSUMER. THIS (B)(6) CONSUMER BEGAN USING THE COLGATE MOTION ADULT TOOTHBRUSH (LOT# 2498KE) APPROX ONE YEAR PRIOR TO THE REPORT, BRUSHING DAILY AND REPLACING THE BATTERIES, AS NEEDED. ON (B)(6) 2011, THE TOOTHBRUSH EXPLODED THIRTY SECONDS AFTER SHE BEGAN BRUSHING AND MADE A VERY LOUD CRACK SOUND. AS A RESULT, SHE EXPERIENCED RINGING IN HER EARS AND SOME HEARING LOSS IN HER RIGHT EAR. THE EVENTS LASTED FOR APPROX TWO HOURS AND SHE DID NOT CONSULT A HEALTH CARE PROFESSIONAL. SHE DISCONTINUED USE OF THE TOOTHBRUSH ON (B)(6) 2011. AT THE TIME OF THE REPORT, THE CONSUMER HAD RECOVERED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLGATE MOTION ADULT TOOTHBRUSH MOTION TOOTHBRUSH JEQ HI-P (XIAMEN) PRECISION PLASTIC MANUFACTURING CO. 2498KE

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other