BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKYLITE TIPLESS NITINOL STONE BASKET

    MDR report key: 4780722 · Received May 15, 2015

    Report

    Report Number
    1018233-2015-00149
    Event Type
    Malfunction
    Date Received
    May 15, 2015
    Report Date
    April 21, 2015
    Manufacturer
    PRODUCTOS PARA EL CIUDADO DE LA SALUD
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STONE BASKET BROKE DURING A PROCEDURE. NO PIECES WERE LEFT IN THE PATIENT AND NO INJURY OCCURRED TO THE PATIENT. THERE WERE NO COMPLICATIONS TO THE PROCEDURE. THE PHYSICIAN USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319794 SKYLITE TIPLESS NITINOL STONE BASKET FFL PRODUCTOS PARA EL CIUDADO DE LA SALUD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1