BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BANDER URETERAL DIVERSION STENT SET

    MDR report key: 6181701 · Received December 16, 2016

    Report

    Report Number
    1820334-2016-01509
    Event Type
    Injury
    Date Received
    December 16, 2016
    Report Date
    September 1, 2017
    Manufacturer
    COOK INC
    Product Code
    FAD
    UDI-DI
    00827002180703
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION ¿ EVALUATION: THE BANDER URETERAL DIVERSION STENT SET WAS NOT RETURNED FOR AN EVALUATION; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. THE COMPLAINT REPORT THAT THE STENT CLOGGED IMMEDIATELY WAS UNABLE TO BE CONFIRMED. BASED ON THE INFORMATION PROVIDED, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED OR ESTABLISHED AT THIS TIME. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO SHIPPING. A REVIEW OF THE DEVICE HISTORY RECORD INDICATED THAT THERE WERE NO NON-CONFORMANCES FOR THIS LOT NUMBER. ADDITIONALLY, A REVIEW OF COMPLAINT HISTORY REVEALED THIS COMPLAINT TO BE ONE OF TWO COMPLAINTS WITH THIS LOT NUMBER 7021020. THE OTHER COMPLAINT WAS REPORTED BY THE SAME CUSTOMER REFERENCING THE SAME DEVICE WITH A DEFECT OF ¿TOO SOFT, SLIPS OFF TOO EASILY.¿ BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT; NO FURTHER ACTION IS REQUIRED. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND THE WILL CONTINUE TO MONITOR THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE URETERAL STENT PRODUCT ¿CLOGS IMMEDIATELY.¿ THE REPORTER STATED ¿STENT SHOULD BE REPLACED LATEST AFTER FOUR MONTHS BECAUSE CLOG IMMEDIATELY.¿ THE PATIENT REQUIRED AN ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833023 BANDER URETERAL DIVERSION STENT SET FAD STENT, URETERAL FAD COOK INC N/A 00827002180703

    Patients

    Seq Age Sex Outcome Treatment
    1