BEUDAMED
    FDA Adverse Event Death Summary report: N

    UROLIFT

    MDR report key: 9426195 · Received December 5, 2019

    Report

    Report Number
    MW5091477
    Event Type
    Death
    Date Received
    December 5, 2019
    Date of Event
    July 5, 2019
    Report Date
    December 3, 2019
    Manufacturer
    TELEFLEX / NEOTRACT, INC.
    Product Code
    PEW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY FATHER HAD A UROLIFT DEVICE IMPLANTED. WITHIN TWO WEEKS HE DEVELOPED A URINARY TRACT INFECTION. AFTER A WEEK OF TREATMENT WITH ORAL ANTIBIOTICS, THE URINE BACKED INTO HIS KIDNEY CAUSING KIDNEY FAILURE AND PRECIPITATED A STROKE. AFTER APPROX 10 DAYS OF HOSPITALIZATION HE HAD ANOTHER STROKE WHICH ULTIMATELY CAUSED HIS DEATH. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1215312 UROLIFT IMPLANTABLE TRANSPROSTATIC TISSUE RETRACTOR SYSTEM PEW TELEFLEX / NEOTRACT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Death| H