BEUDAMED
    FDA Adverse Event Other Summary report: N

    THE SPANNER TEMORARY PROSTATIC STENT

    MDR report key: 2573806 · Received May 2, 2012

    Report

    Report Number
    3005249627-2012-00001
    Event Type
    Other
    Date Received
    May 2, 2012
    Date of Event
    March 31, 2012
    Report Date
    April 30, 2012
    Product Code
    NZC
    PMA / PMN Number
    P060010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. NO DEVICE MALFUNCTION WAS REPORTED. A REVIEW OF THE DHR WAS NOT PERFORMED DUE TO THE LOT NUMBER NOT BEING PROVIDED. ACTUAL DEVICE NOT EVALUATED. NO EVALUATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    THE PATIENT HAD AN EPISODE OF BLEEDING (GROSS HEMATURIA) THAT BEGAN AFTER HIS LAST SPANNER INSERTION ON (B)(6) 2012. THE BLEEDING STARTED AFTER THE PATIENT MOWED HIS LAWN. PHYSICIAN DETERMINED HEMATURIA SECONDARY TO SPANNER TRAUMA. THE PATIENT WENT TO THE EMERGENCY ROOM ON (B)(6) 2012, WHERE THE SPANNER WAS REMOVED WITHOUT DIFFICULTY AND A FOLEY CATHETER WAS INSERTED. ON (B)(6) 2012 THE FOLEY CATHETER WAS REMOVED AND ANOTHER SPANNER WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE SPANNER TEMORARY PROSTATIC STENT TEMPORARY PROSTATIC STENT NZC SPNR-8

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention