BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSA SOFT URETERAL STENT SET

    MDR report key: 2082849 · Received May 3, 2011

    Report

    Report Number
    1825146-2011-00022
    Event Type
    Injury
    Date Received
    May 3, 2011
    Date of Event
    April 12, 2011
    Report Date
    May 3, 2011
    Manufacturer
    COOK UROLOGICAL, INC.
    Product Code
    FAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME, UPON RECEIPT OF THE DEVICE, AN EVALUATION WILL BE FORWARDED. AS STATED, THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT IN THE CLINIC SETTING WITHOUT SUCCESS, THE PATIENT WAS TAKEN TO THE OPERATING ROOM NOTING THE PHYSICIAN USED A LASER TO BREAK UP THE REMAINING STONES, A RIGID SCOPE, WIRE GUIDE AND A SNARE TO REMOVE THE REMAINING PORTION OF THE STENT. THE PHYSICIAN FEELS THE STONES PREVENTED THE STENT REMOVAL. NO FURTHER DIFFICULTIES WITH PATIENT REPORTED.

    Description of Event or Problem · 1

    MD UNABLE TO REMOVE STENT IN CLINIC, SENT PT TO OPERATING ROOM, STENT RESISTED UPON REMOVAL AND BROKE IN TWO. X-RAY INDICATED STONE BURDEN SURROUNDING REMAINING STENT PORTION IN LOWER 1/3 URETER. RIGID SCOPE / WIRE INTRODUCED, LEFTOVER ESWL STONES TREATED VIA HOLMIUM, REMAINING STENT REMOVED. MD FEELS STONES PREVENTED STENT REMOVAL. REMAINING PORTION REMOVED FROM PT VIA REP PROVIDED NSNARE, NO FURTHER DIFFICULTIES WITH PATIENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention