BEUDAMED
    FDA Adverse Event Other Summary report: N

    THE SPANNER TEMPORARY PROSTATIC STENT

    MDR report key: 1542584 · Received November 18, 2009

    Report

    Report Number
    3005249627-2009-00003
    Event Type
    Other
    Date Received
    November 18, 2009
    Date of Event
    October 5, 2009
    Report Date
    November 18, 2009
    Manufacturer
    ABBEYMOOR MEDICAL INC.
    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. METHOD - NOT APPLICABLE (ACTUAL DEVICE WERE NOT EVALUATED). CONCLUSIONS - DEVICE NOT RETURNED - NO EVAL WILL BE PERFORMED.

    Description of Event or Problem · 1

    WHILE SOLICITING PRODUCT PERFORMANCE FEEDBACK FROM A PT, THE DEVICE MFR LEARNED THE PT HAD GONE TO THE EMERGENCY ROOM (ER) FOR BURNING ON URINATION FOUR DAYS AFTER SPANNER INSERTION. THE PT WAS GIVEN ANTIBIOTICS FOR A URINARY TRACK INFECTION; THE SPANNER STENT WAS NOT REMOVED. THE PT STATED HE WAS FEELING BETTER BY THE NEXT MORNING. HE CONTACTED THE NURSE AT THE PHYSICIAN'S OFFICE TO NOTIFY THEM, THEY STATED THAT THIS WAS FINE AND THAT HE DIDN'T NEED TO COME IN FOR ANY SPECIAL FOLLOW-UP. THE SPANNER STENT WAS INSERTED ON (B)(6) 2009. INDICATION FOR USE WAS URINARY RETENTION. DEVICE REMOVAL DATE IS UNK BUT THE PHYSICIAN STATED THE STENT WAS REMOVED AS SCHEDULE WITH NO UNTOWARD ADVERSE EFFECTS.

    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-6HA 216

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention