BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUM CRAYLA POWERED TOOTHBRUSH

    MDR report key: 15217665 · Received August 12, 2022

    Report

    Report Number
    0001413787-2022-00299
    Event Type
    Malfunction
    Date Received
    August 12, 2022
    Date of Event
    February 11, 2019
    Report Date
    February 11, 2019
    Manufacturer
    SUNSTAR AMERICAS INC.
    Product Code
    JEQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR REPORT IS GENERATED RETROSPECTIVELY BASED ON COMPLAINTS AUDIT.

    Additional Manufacturer Narrative · 0

    THIS MDR REPORT IS GENERATED RETROSPECTIVELY BASED ON COMPLAINTS AUDIT. THE CORRECTIONS TO THE ORIGINAL MDR SUBMITTED ARE AS FOLLOWS: SECTION D2: WRONG PROBLEM CODE EFW CHANGED TO JEQ.

    Description of Event or Problem · 0

    CONSUMER BOUGHT A PACKAGE OF THE GUM CRAYOLA POWERED TOOTHBRUSHES AND THE BRISTLES WERE COMING OFF AND FELL INTO HER MOUTH.

    Description of Event or Problem · 0

    CONSUMER BOUGHT A PACKAGE OF THE GUM CRAYOLA POWERED TOOTHBRUSHES AND THE BRISTLES WERE COMING OFF AND FELL INTO HER MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2576209 GUM CRAYLA POWERED TOOTHBRUSH TOOTHBRUSH, POWERED JEQ SUNSTAR AMERICAS INC. 2272RC
    2865208 GUM CRAYLA POWERED TOOTHBRUSH TOOTHBRUSH, POWERED JEQ SUNSTAR AMERICAS INC. 2272RC

    Patients

    Seq Age Sex Outcome Treatment
    1 Female