BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWANSON FLEXIBLE HINGE TOE WITH GROMMETS

    MDR report key: 4920161 · Received July 16, 2015

    Report

    Report Number
    1043534-2015-00041
    Event Type
    Injury
    Date Received
    July 16, 2015
    Date of Event
    June 16, 2015
    Report Date
    July 16, 2015
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION NOT COMPLETE. PRODUCT HAS NOT BEEN RETURNED. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    ALLEGEDLY, SURGERY WAS DONE ON A PATIENT AND SWANSON IMPLANT WAS PUT IN THE PATIENTS 1ST MPJ JOINT. THE DOCTOR BELIEVES THAT THE PATIENT IS HAVING AN ALLERGIC REACTION TO THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462554 SWANSON FLEXIBLE HINGE TOE WITH GROMMETS SMALL JOINT COMPONENT KWD WRIGHT MEDICAL TECHNOLOGY, INC. 1561290

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other