BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRIDABABY

    MDR report key: 9465875 · Received December 12, 2019

    Report

    Report Number
    MW5091633
    Event Type
    Injury
    Date Received
    December 12, 2019
    Date of Event
    November 12, 2019
    Report Date
    December 12, 2019
    Manufacturer
    FRIDABABY LLC
    Product Code
    EFW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    I PURCHASED A FRIDABABY SMILEFRIDA TODDLER TOOTHBRUSH FROM MY LOCAL (B)(6) STORE A FEW WEEKS AGO. TODAY, WHILE MY (B)(6) TODDLER AND I WERE BRUSHING OUR TEETH TOGETHER, TO MY SHOCK AND HORROR, HE SPAT OUT A 1 - INCH LONG METAL CLIP. THE METAL CLIP IS A COMPONENT OF THE TOOTHBRUSH, AND EMERGED WHEN HE CHEWED THROUGH THE RUBBER CASING. ONCE I REALIZED THE SOURCE, A BRIEF ONLINE SEARCH REVEALED MANY WARNINGS ABOUT THIS PRODUCT FROM OTHER PARENTS. THIS PRODUCT IS HORRIFICALLY DANGEROUS AND ABSOLUTELY SHOULD NOT BE SOLD. FRIDABABY SMILEFRIDA TOOTHHUGGER. HTTPS://FRIDABABY.COM/PROUCTS/SMILEFRIDA. PURCHASE DATE: 11/01/2019, THIS DATE IS AN ESTIMATE. THE PRODUCT WAS NOT DAMAGED BEFORE THE INCIDENT. THE PRODUCT WAS NOT MODIFIED BEFORE THE INCIDENT. DOCUMENT NO: I19B0156A. REPORT NUMBER: 20191112-10333-2147376608.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1257818 FRIDABABY TOOTHBRUSH, MANUAL EFW FRIDABABY LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR