BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LSE SOF-FLEX MULTI-LENGTH URETERAL STENT SET

    MDR report key: 7424905 · Received April 12, 2018

    Report

    Report Number
    1820334-2018-01065
    Event Type
    Malfunction
    Date Received
    April 12, 2018
    Date of Event
    January 23, 2015
    Report Date
    April 12, 2018
    Manufacturer
    COOK INC
    Product Code
    FAD
    UDI-DI
    00827002303508
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING FILED AFTER THE ASSOCIATED COMPLAINT WAS REVIEWED UNDER REMEDIATION PROTOCOL CAPA (B)(4), COMPLAINT/MDR RETROSPECTIVE REVIEW AND REMEDIATION AND REASSESSED AS REPORTABLE. ADDITIONAL COMPLAINT INVESTIGATION AND RECORD REMEDIATION WAS NOT PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THERE WAS A CUT IN THE PIGTAIL. IT WAS FURTHER NOTED THAT THERE WAS A TEAR STARTING FROM THE SIDEPORT ALL THE WAY THROUGH THE END OF THE URETERAL STENT. THE CUSTOMER USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE AND NO PATIENT HARMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266964 LSE SOF-FLEX MULTI-LENGTH URETERAL STENT SET FAD STENT, URETERAL FAD COOK INC 00827002303508

    Patients

    Seq Age Sex Outcome Treatment
    1