BEUDAMED
    FDA Adverse Event Summary report: N

    THE FIRST YEARS TEETHING RING

    MDR report key: 7910122 · Received September 25, 2018

    Report

    Report Number
    MW5080104
    Date Received
    September 25, 2018
    Date of Event
    September 6, 2018
    Report Date
    September 6, 2018
    Manufacturer
    LEARNING CURVE BRANDS, INC., / TOMY INTERNATIONAL INC. C/O RC2 (H.K.) LTD.
    Product Code
    MEF
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I WORK FOR A COUNTY HEALTH DEPT IN (B)(6). I LEARNED FROM A COLLEAGUE THAT THE (B)(6) COUNTY DEPT OF HEALTH FOUND THAT THIS PRODUCT CONTAINS AN INTERNAL PART MADE WITH A HIGH LEVEL OF LEAD. WHEN A YOUNG CHILD PUTS THIS PHONE IN THE MOUTH (WHICH IS AN INTENDED, ADVERTISED FEATURE OF THE PRODUCT), SALIVA ENTERS THE HOLES IN THE "MICROPHONE" OF THE TOY, CONTACTS THE LEAD COMPONENT AND GIVES THE CHILD A SWEET SENSATION. THE (B)(6) DOH REPORTS SENDING THIS FINDING TO THE CPSC OVER A YEAR AGO, BASED ON ANALYSIS DONE BY A CPSC-ACCREDITED LABORATORY. HOWEVER, THE PRODUCT IS STILL AVAILABLE TO THE PUBLIC (SEE (B)(6) AND OTHER WEB SITES). INCIDENT LOCATION: (B)(6). DOCUMENT NUMBER: (B)(4). REPORT NUMBER: (B)(4). PRODUCT DESCRIPTION: THE FIRST YEARS MY PHONE MUSICAL TOY: LOOKS LIKE A VERY SIMPLE CELL PHONE WITH A SOFT TEETHING RING AROUND THE PERIMETER. INVESTIGATORS: (B)(6), DIR, ENVIRONMENTAL HEALTH, (B)(6) COUNTY DEPT OF HEALTH, (B)(6), CPSC REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749361 THE FIRST YEARS TEETHING RING RING, TEETHING, NON-FLUID FILLED MEF LEARNING CURVE BRANDS, INC., / TOMY INTERNATIONAL INC. C/O RC2 (H.K.) LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1