BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROLIFT

    MDR report key: 8041183 · Received November 6, 2018

    Report

    Report Number
    8041183
    Event Type
    Malfunction
    Date Received
    November 6, 2018
    Date of Event
    September 7, 2018
    Report Date
    October 25, 2018
    Manufacturer
    NEOTRACT, INC.
    Product Code
    PEW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING CYSTOSCOPY WITH TRANSURETHRAL PLACEMENT OF UROLIFT IMPLANTS, SURGEON ATTEMPTED TO DEPLOY 1 OF 2 ON THE LEFT LATERAL LOBE AND IT DID NOT DEPLOY. A TOTAL OF 5 UROLIFT IMPLANTS WERE USED, HOWEVER ONLY 4 WERE ACTUALLY PLACED. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    882173 UROLIFT IMPLANTABLE TRANSPROSTATIC TISSUE RETRACTOR SYSTEM PEW NEOTRACT, INC. UL400-4

    Patients

    Seq Age Sex Outcome Treatment
    1 25185 DA