BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE SPANNER TEMPORARY PROSTATIC STENT

    MDR report key: 16603272 · Received March 23, 2023

    Report

    Report Number
    1000305746-2023-00005
    Event Type
    Injury
    Date Received
    March 23, 2023
    Date of Event
    February 23, 2015
    Report Date
    March 23, 2023
    Manufacturer
    SRS MEDICAL
    Product Code
    NZC
    PMA / PMN Number
    P060010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WHEN THIS EVENT WAS INITIALLY RECEIVED, OUR PROCEDURES FOR DETERMINING MDR DID NOT CHARACTERIZE THIS EVENT AS REPORTABLE IN ACCORDANCE WITH 21 CFR 803.3(W). WE HAVE RECENTLY REVISED OUR PROCEDURES TO BROADEN THE INTERPRETATION OF 21 CFR 803.3(W)(3) AND ARE RETROSPECTIVELY REPORTING PREVIOUS EVENTS DATING BACK TO 2013.

    Description of Event or Problem · 0

    A TEMPORARY PROSTATIC STENT WAS PLACED BY A UROLOGIST ON (B)(6) 2015. ON (B)(6) 2015, THE PATIENT REPORTED URINARY RETENTION. ON (B)(6) 2015, THE UROLOGIST REMOVED THE STENT AND NOTED THAT THE STENT'S BALLOON WAS ALREADY DEFLATED AND THE STENT WAS PARTIALLY EXPELLED INTO THE PENILE URETHRA. THE PATIENT REPORTED ACCIDENTALLY PULLING THE STENT'S REMOVAL TETHER AND IT IS BELIEVED THAT THE PATIENT DEFLATED THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY BUT THE STENT DID NOT ALLEVIATE THE PATIENT'S RETENTION SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1444685 THE SPANNER TEMPORARY PROSTATIC STENT STENT, URETHRAL, PROSTATIC, SEMI-PERMANENT NZC SRS MEDICAL SPNR-9HA WP01337

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention