BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROLIFT

    MDR report key: 13949755 · Received March 29, 2022

    Report

    Report Number
    MW5108615
    Event Type
    Malfunction
    Date Received
    March 29, 2022
    Date of Event
    March 24, 2022
    Report Date
    March 28, 2022
    Manufacturer
    NEOTRACT, INC.
    Product Code
    PEW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NEOTRACT, INC. UROLIFT SYSTEM WITH HANDLE RELEASE TOOL LOT # 73K2100525 REF # UL400-4 DID NOT FIRE NEEDLE WHEN ACTIVATED IN PATIENT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157250 UROLIFT IMPLANTABLE TRANSPROSTATIC TISSUE RETRACTOR SYSTEM PEW NEOTRACT, INC. 73K2100525

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown