BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOTRACT UROLIFT SYSTEM

    MDR report key: 12849499 · Received November 19, 2021

    Report

    Report Number
    3015181082-2021-00038
    Event Type
    Injury
    Date Received
    November 19, 2021
    Date of Event
    October 5, 2021
    Report Date
    November 19, 2021
    Manufacturer
    NEOTRACT, INC.
    Product Code
    PEW
    UDI-DI
    00814932020001
    PMA / PMN Number
    K193269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2021, NEOTRACT WAS MADE AWARE OF A PATIENT WHO RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON (B)(6) 2021. AS A PRE-PROCEDURAL ANTIBIOTIC, THE PATIENT WAS PRESCRIBED ANCEF. IN THE DAYS FOLLOWING THE PROCEDURE (TIMING UNKNOWN), THE PATIENT UNDERWENT EMERGENCY HEMORRHOID SURGERY WHICH UROLOGIST SAID WAS ¿UNRELATED TO THE PUL PROCEDURE.¿ POST HEMORRHOID SURGERY, THE PATIENT EXPERIENCED URINARY RETENTION. ON (B)(6) 2021, HE WAS ADMITTED TO THE HOSPITAL FOR A C. DIFFICILE INFECTION, THOUGHT TO BE RELATED TO THE ANCEF MEDICATION AND NOT TO THE PUL PROCEDURE. CT IMAGING REVEALED AIR IN HIS PELVIS. PATIENT WAS TRANSFERRED TO THE ICU FOR TWO WEEKS FOR UNKNOWN REASONS, HAS SINCE BEEN DISCHARGED AND REPORTED AS DOING WELL. THE UROLOGIST STATED THAT HE BELIEVED THE INFECTION, URINARY RETENTION, AND PELVIC AIR WERE UNRELATED TO THE PUL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1741556 NEOTRACT UROLIFT SYSTEM UROLIFT SYSTEM PEW NEOTRACT, INC. UROLIFT SYSTEM UNKNOWN 00814932020001

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R