BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFT PCK;ENV;US PRO;CPN;72/BX

    MDR report key: 14569232 · Received June 1, 2022

    Report

    Report Number
    0001413787-2022-00177
    Event Type
    Injury
    Date Received
    June 1, 2022
    Date of Event
    May 5, 2022
    Report Date
    May 6, 2022
    Manufacturer
    SUNSTAR AMERICAS INC.
    Product Code
    JET
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    CONSUMER WAS USING THE SOFT-PICK AND SWALLOWED THE ENTIRE PICK AND WENT TO THE ER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2413444 SOFT PCK;ENV;US PRO;CPN;72/BX PICK, MASSAGING JET SUNSTAR AMERICAS INC. 632DB

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention