BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSA FIRM URETERAL STENT SET

    MDR report key: 1812340 · Received August 12, 2010

    Report

    Report Number
    1825146-2010-00028
    Event Type
    Injury
    Date Received
    August 12, 2010
    Date of Event
    July 7, 2010
    Report Date
    August 12, 2010
    Manufacturer
    COOK UROLOGICAL, INC.
    Product Code
    FAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION AND HAVE RECEIVED LIMITED INFORMATION IN REGARD TO WHAT HAD TRANSPIRED CAUSING THE URETERAL STENT REMOVAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED CONCERNING THE PLACEMENT OF THE NEPHROSTOMY TUBE, INDWELLING TIME FOR THE STENT AND THE PATIENT'S CURRENT STATUS. UPON RECEIPT OF THE PRODUCT AND OR ADDITIONAL INFORMATION, IT WILL BE FORWARDED.

    Description of Event or Problem · 1

    AN INJURY AND THE PATIENT HAD TO HAVE A NEPHROSTOMY TUBE. HE DOES NOT WANT TO USE THE FIRM STENT. PATIENT JUST PULLED IT OUT WITH HIS HAND. PATIENT HAD A NEPHROSTOMY TUBE PUT IN ON (B)(6), 2010, AND HE HAS BEEN DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSA FIRM URETERAL STENT SET FAD STENT, URETERAL FAD COOK UROLOGICAL, INC. NA U1949162

    Patients

    Seq Age Sex Outcome Treatment
    1