BEUDAMED
    FDA Adverse Event Other Summary report: N

    THE SPANNER TEMPORARY PROSTATIC STENT

    MDR report key: 1821643 · Received August 20, 2010

    Report

    Report Number
    3005249627-2010-00005
    Event Type
    Other
    Date Received
    August 20, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 26, 2010
    Manufacturer
    ABBEYMOOR MEDICAL, INC.
    Product Code
    MER
    PMA / PMN Number
    P060010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. THE PATIENT IS A DIABETIC WHICH IS A RISK FACTOR FOR DEVELOPING INFECTIONS.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED A PATIENT WITH SEPSIS AFTER SPANNER STENT REMOVAL. THE PATIENT WENT TO THE ER AFTER DEVELOPING VIOLENT SHAKING CHILLS AND FEVER TWO HOURS AFTER STENT REMOVAL. THE PATIENT WAS HOSPITALIZED AND PLACED ON IV ZOSYN AND LEVAQUIN ANTIBIOTICS. HE WAS HOSPITALIZED FROM MONDAY TO SUNDAY (6 DAYS). PATIENT'S CATHETER WAS REMOVED DURING HOSPITALIZATION. PHYSICIAN STATES IN AN EMAIL DATED (B)(4) PATIENT IS DOING FINE. FOLLOW UP INFORMATION FROM THE PHYSICIAN STATES THE PATIENT HAD HIS SPANNER PLACED ON (B)(6) 2010 AND REMOVED ON (B)(6) 2010 (5 1/2 WEEKS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE SPANNER TEMPORARY PROSTATIC STENT TEMPORARY PROSTATIC STENT MER ABBEYMOOR MEDICAL, INC. SPNR-9HA 240

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R