BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 8816748 · Received July 23, 2019

    Report

    Report Number
    1820334-2019-01766
    Event Type
    Malfunction
    Date Received
    July 23, 2019
    Report Date
    August 22, 2019
    Manufacturer
    COOK INC
    Product Code
    FAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN OR UNAVAILABLE. INVESTIGATION - EVALUATION. REVIEWS OF THE COMPLAINT HISTORY AND QUALITY CONTROLS WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED DUE TO LACK OF LOT INFORMATION FROM THE USER FACILITY. THE CAUSE OF THE COMPLAINT COULD NOT BE ESTABLISHED. DUE TO LIMITED INFORMATION BEING AVAILABLE AS THIS COMPLAINT WAS RECEIVED SECONDHAND, A PART NUMBER OR PRODUCT FAMILY COULD NOT BE DEFINITIVELY IDENTIFIED. THE HIGHEST SALES VOLUMES TO THIS CUSTOMER WAS FOR UNIVERSA FIRM STENTS AND SO THIS HAD BEEN ASSUMED TO BE THE PRODUCT FAMILY. A DEVICE HISTORY RECORD REVIEW AND SEARCH FOR ADDITIONAL COMPLAINTS ON THE SAME LOT COULD NOT BE CARRIED OUT AS THE LOT NUMBER IS UNKNOWN. QUALITY CONTROLS WERE REVIEWED AND FOUND TO BE IN PLACE FOR THE LENGTH OF THE STENT AND THE COILS OF THE STENT. THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED, AND IT WAS DETERMINED THAT NO ADDITIONAL RISK MITIGATING ACTIVITY IS REQUIRED. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

    Additional Manufacturer Narrative · 1

    OCCUPATION: MATERIALS MANAGER. PMA/510K #: K161236 OR K151051. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED, DURING AN UNSPECIFIED PROCEDURE USING A UNSPECIFIED UNIVERSA STENT, THE STENT ALLEGEDLY MIGRATED TO THE KIDNEY. NO CONSEQUENCES TO THE PATIENT HAVE BEEN REPORTED AS A RESULT OF THIS OCCURRENCE. ADDITIONAL DETAILS REGARDING THE PATIENT AND EVENT HAVE BEEN REQUESTED. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610196 UNKNOWN FAD STENT, URETERAL FAD COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1