BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO TB;CAP;42MM;INTL TRI

    MDR report key: 14713021 · Received June 16, 2022

    Report

    Report Number
    0001413787-2022-00182
    Event Type
    Malfunction
    Date Received
    June 16, 2022
    Date of Event
    March 14, 2022
    Report Date
    June 6, 2022
    Manufacturer
    SUNSTAR AMERICAS INC.
    Product Code
    EFW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    PHARMACY RECEIVED A COMPLAINT FROM A CONSUMER WHO PURCHASED THE PRODUCT FROM THEIR STORE. THE CONSUMER MENTIONED THAT UPON OPENING THE PACKAGING, A LOT OF BRISTLES FELL OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1240621 ORTHO TB;CAP;42MM;INTL TRI TOOTHBRUSH, MANUAL EFW SUNSTAR AMERICAS INC. 124MH

    Patients

    Seq Age Sex Outcome Treatment
    1 Female