BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOURNI-COT

    MDR report key: 5546487 · Received April 4, 2016

    Report

    Report Number
    1832653-2016-00001
    Event Type
    Injury
    Date Received
    April 4, 2016
    Date of Event
    September 27, 2012
    Report Date
    March 17, 2016
    Manufacturer
    MAR-MED CO.
    Product Code
    KCY
    PMA / PMN Number
    K853472
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE BEEN INFORMED OF A FAILURE TO FOLLOW INSTRUCTION FOR USE, RESULTING IN DOCTOR'S FAILURE TO REMOVE DEVICE FROM PATIENT DURING THE SPECIFIED TIME. THIS FAILURE CAUSED HARM TO PATIENT, RESULTING IN NECROSIS AND THEREFORE REMOVAL OF A TOE. DEVICE PERFORMED TO SPECIFICATIONS, AND RESULTING HARM WAS CAUSED BY USER ERROR, NOT DEVICE.

    Description of Event or Problem · 1

    OUR TOURNI-COT PRODUCT WAS USED IN A TOE PROCEDURE ON THE PATIENT, (B)(6). THE TOURNI-COT PRODUCT IS A TYPE OF TOURNIQUET FOR DIGITS. THE DOCTOR REMOVED THE WARNING TAG FROM THE DEVICE AND THEREAFTER FORGOT THE DEVICE ON THE PATIENT AFTER THE PROCEDURE WAS COMPLETED. THE EXTENDED USE OF THE DEVICE ON THE PATIENT'S TOE RESULTED IN NECROSIS OF THE PATIENT TOE, LEADING TO AMPUTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200090 TOURNI-COT TOURNI-COT KCY MAR-MED CO. TCS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Disability