BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAROL PLATINUM FLAT WIRE STONE BASKET

    MDR report key: 122286 · Received September 23, 1997

    Report

    Report Number
    122286
    Event Type
    Injury
    Date Received
    September 23, 1997
    Date of Event
    September 18, 1997
    Report Date
    September 22, 1997
    Manufacturer
    BARD UROLOGICAL DIVISION C.R. BARD, INC.
    Product Code
    FFL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT CAME TO SURGERY FOR REMOVAL OF URETERAL CALCULUS. THE UROLOGIST WAS ABLE TO GET THE STONE IN THE STONE BASKET, BUT THEN THE BASKET BECAME STUCK IN THE URETER. THE BASKET OF THE STONE WAS CUT & LEFT IN; FUTURE SURGERY PROBABLE. COULD BE USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAROL PLATINUM FLAT WIRE STONE BASKET URETEROSCOPIC 3 FR. FLAT WIRE STONE BASKET FFL BARD UROLOGICAL DIVISION C.R. BARD, INC. * 03KGA785

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R FUTURE SURGERY DATE UNK TO WRITER| PT TRANSFERRED TO ANOTHER FACILITY.