BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOUBLE PIGTAIL URETEREL STENT, 6 FR, 24 CM LONG

    MDR report key: 28930 · Received August 30, 1995

    Report

    Report Number
    28930
    Event Type
    Malfunction
    Date Received
    August 30, 1995
    Date of Event
    February 16, 1995
    Report Date
    August 1, 1995
    Manufacturer
    C.R. BARD, INC.
    Product Code
    FAD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT DIAGNOSED WITH RT GRADE PYELOGRAM, LITHOTROPSY, & STENT REPLACEMENT. A DOUBLE PIGTAIL STENT WAS PLACED IN RT URETER; IT MIGRATED TO WHERE THE TIP WAS IN THE LOWER URETER. A SECOND STENT WAS PLACED & IT WAS NORMALLY LOCATED. EACH URETEREL STENT WAS 6 FRENCH, 24 CM LONG. (EACH STENT HAD SAME SERIAL # & LOT #). LITHOTRIPSY DESTROYED THE STONES, & PT PASSED THE STONES. PT RETURNED TO THE HOSP 6 WKS LATER FOR REMOVAL OF THE STENTS. THIS WAS DONE WITHOUT ANY DIFFICULTY. PT HAD ON UNREMARKABLE POST-OP COURSE & WAS DISCHARGED IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOUBLE PIGTAIL URETEREL STENT, 6 FR, 24 CM LONG Implant DOUBLE PIGTAIL URETEREL STENT FAD C.R. BARD, INC. NI 03FB2022

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other