BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLIVE WIRE

    MDR report key: 14459677 · Received May 20, 2022

    Report

    Report Number
    3008650117-2022-00055
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Report Date
    May 19, 2022
    Manufacturer
    PARAGON 28, INC
    Product Code
    HXI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    LIMITED INFORMATION IS AVAILABLE. REPORT 2 OF 2 FROM THIS EVENT. (B)(4).

    Description of Event or Problem · 0

    AN OLIVE WIRE WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526183 OLIVE WIRE HXI PARAGON 28, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown