BEUDAMED
    FDA Adverse Event Other Summary report: N

    THE SPANNER TEMPORARY PROSTATIC STENT

    MDR report key: 1971890 · Received January 17, 2011

    Report

    Report Number
    3005249627-2010-00007
    Event Type
    Other
    Date Received
    January 17, 2011
    Date of Event
    November 30, 2010
    Report Date
    January 14, 2011
    Manufacturer
    ABBEYMOOR MEDICAL INC.
    Product Code
    NZC
    PMA / PMN Number
    P060010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DHR WAS NOT PERFORMED. EVERY DEVICE LOT IS VERIFIED AS STERILE BEFORE RELEASE INTO INVENTORY. URINARY TRACT INFECTIONS ARE NOT A SIGNIFICANT RATE OF OCCURRENCE.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT ONE OF HIS SPANNER PATIENTS HAD DEVELOPED SEPSIS. THE PT WAS ADMITTED WITH (B)(6) TO ICU AND WAS HOSPITALIZED FROM (B)(6) 2010. THE SPANNER WAS INITIALLY PLACED ON (B)(6) 2010, FOR URINARY RETENTION. SEPSIS WAS DIAGNOSED ON (B)(6) 2010, THE DAY THE STENT WAS REMOVED. THE PT IS CURRENTLY IS A REHAB HOSPITAL.

    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-6XX

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R