BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE SPANNER TEMPORARY PROSTATIC STENT

    MDR report key: 1479296 · Received September 18, 2009

    Report

    Report Number
    3005249627-2009-00002
    Event Type
    Injury
    Date Received
    September 18, 2009
    Report Date
    September 18, 2009
    Manufacturer
    ABBEYMOOR MEDICAL INC.
    Product Code
    NZC
    PMA / PMN Number
    P060010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN STATED THE EVENT MAY BE RELATED TO MECHANICAL DEFECT HOWEVER, HE DID NOT RECOVER THE DEVICE TO SEND BACK FOR ANALYSIS. DEVICE SIZE AND LOT NUMBER ARE UNK THEREFORE A REVIEW OF DEVICE HISTORY RECORDS WAS NOT PERFORMED. ACTUAL DEVICES WERE NOT EVALUATED.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED AN ADVERSE EVENT IN WHICH THE SPANNER DEVICE BECAME SPONTANEOUSLY DISLODGED, AND HAD TO BE REMOVED FROM THE PT'S BLADDER ENDOSCOPICALLY. NO COMPLICATIONS WERE REPORTED FOR THE PT, AND NO FOLLOW-UP TREATMENT WAS REQUIRED. INDICATION FOR USE WAS URINARY RETENTION. DATES OF INSERTION AND REMOVAL WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE SPANNER TEMPORARY PROSTATIC STENT TEMPORARY PROSTATIC STENT NZC ABBEYMOOR MEDICAL INC. SPNR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention