BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FILIFORM DOUBLE PIGTAIL URETERAL STENT SET

    MDR report key: 7221023 · Received January 26, 2018

    Report

    Report Number
    1820334-2018-00105
    Event Type
    Injury
    Date Received
    January 26, 2018
    Report Date
    April 18, 2018
    Manufacturer
    COOK INC
    Product Code
    FAD
    UDI-DI
    00827002151468
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT CODE: INFECTION, DEVICE CODE: NO INFORMATION. PMA/510(K) #: PREAMENDMENT. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    ; INVESTIGATION ¿ EVALUATION THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION. NO PHOTOS OR IMAGING WAS PROVIDED. WITHOUT THE COMPLAINT DEVICE, A PHYSICAL INVESTIGATION WAS NOT ABLE TO BE COMPLETED. A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL DATA AND SPECIFICATIONS WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO OTHER NON-CONFORMANCES ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER 7801438. A REVIEW OF COMPLAINT HISTORY REVEALED NO OTHER COMPLAINTS ASSOCIATED WITH LOT NUMBER 7801438. THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE THE STERILITY OF THE DEVICE PRIOR TO SHIPPING. REVIEW OF PRODUCTION AND QUALITY DOCUMENTATION OF THE SUSPECT DEVICE DID NOT REVEAL ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING OR QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. BASED ON THE PROVIDED INFORMATION A DEFINITIVE CAUSE OF THE ALLEGED COMPLAINT ISSUE CANNOT BE DETERMINED. INFORMATION CONCERNING THE PATIENTS CURRENT STATE OR PROGNOSIS HAS NOT BEEN PROVIDED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAS ACQUIRED AN INFECTION. THE PATIENT HAS A FILIFORM DOUBLE PIGTAIL URETERAL STENT IMPLANTED. REPORTER STATES, ¿POSSIBILITY OF AN ISSUE WITH THE DEVICE.¿ ADDITIONAL EVENT, DEVICE AND PATIENT STATUS INFORMATION HAS BEEN REQUESTED BUT NO NEW INFORMATION HAS PROVIDED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64631 FILIFORM DOUBLE PIGTAIL URETERAL STENT SET FAD STENT, URETERAL FAD COOK INC G15146 00827002151468

    Patients

    Seq Age Sex Outcome Treatment
    1 Other