BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET

    MDR report key: 1983855 · Received February 3, 2011

    Report

    Report Number
    1825146-2011-00007
    Event Type
    Injury
    Date Received
    February 3, 2011
    Date of Event
    November 29, 2010
    Report Date
    February 3, 2011
    Manufacturer
    COOK UROLOGICAL, INC.
    Product Code
    FAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED FOR EVAL, A PROPER EVAL CANNOT BE PERFORMED. ATTEMPTS HAVE BEEN MADE TO REACH THE CONTACT AT THE FACILITY WITHOUT SUCCESS, HOWEVER, CONTINUED ATTEMPTS WILL BE MADE.

    Description of Event or Problem · 1

    SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT WAS ORIGINALLY IMPLANTED ON (B)(6) 2010 IN A (B)(6) MALE PT. THE PT'S MOTHER REPORTED THAT PIECES OF THE SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT WERE BEING EXPELLED DURING URINATION. SURGEON ADMITTED CHILD TO PERFORM PROCEDURE TO REMOVE THE STENT. STENT DISINTEGRATED AND PIECES WERE RETAINED REQUIRING SUBSEQUENT PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET FAD STENT, URETERAL FAD COOK UROLOGICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention