BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN PATTIES

    MDR report key: 5351296 · Received January 7, 2016

    Report

    Report Number
    1226348-2016-10032
    Event Type
    Injury
    Date Received
    January 7, 2016
    Product Code
    HBA
    PMA / PMN Number
    PN/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFORMATION IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE AND/OR LOT INFORMATION IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFORMATION DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED US CLAIMING THAT A DOCTOR LEFT 2 CODMAN PATTIES IN THE PATIENT AND REFUSED TO REMOVE IT. PATIENT IS DOING OKAY. AS I TOLD YOU WE HAVE A SITUATION WHERE A SURGEON HAS DECIDED TO LEAVE 2 SURGICAL PATTIES/COTTONOIDS (REF #80-1400, #80-1403, OR #80-1404) IN A PATIENT. THE PROCEDURE WAS A SPINE SURGERY AND OCCURRED IN NOVEMBER, IF I REMEMBER CORRECTLY. (AT THIS TIME I DO NOT HAVE THE ACTUAL DATE OF THE OCCURRENCE.) WE ARE ALSO ACUTELY AWARE OF THE WARNING STATED ON THE PACKAGE INSERT ABOUT NOT LEAVING PATTIES OR STRIPS IN SITU AND THAT FAILURE TO REMOVE THEM MAY RESULT IN A FOREIGN BODY REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10004 CODMAN PATTIES PADDIE, COTTONOID HBA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention