BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHANTOM HINDFOOT TTC/TC NAIL SYSTEM

    MDR report key: 14297156 · Received May 6, 2022

    Report

    Report Number
    3008650117-2022-00050
    Event Type
    Injury
    Date Received
    May 6, 2022
    Date of Event
    April 4, 2022
    Report Date
    May 4, 2022
    Manufacturer
    PARAGON 28, INC.
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    PATIENT REACTION EXPERIENCED WITH NO ALLEGATION OF PRODUCT DEFICIENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1693896 PHANTOM HINDFOOT TTC/TC NAIL SYSTEM PHANTOM HINDFOOT TTC/TC NAIL SYSTEM HSB PARAGON 28, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female