BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IVS TUNNELLER DEVICE

    MDR report key: 3981415 · Received July 24, 2014

    Report

    Report Number
    6000141-2014-00011
    Event Type
    Injury
    Date Received
    July 24, 2014
    Report Date
    June 26, 2014
    Manufacturer
    BALLYMONEY - USS
    Product Code
    FTL
    PMA / PMN Number
    K073164
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    LITERATURE REVIEW: ARTICLE ENTITLED "FUNCTIONAL OUTCOMES FOLLOWING SURGICAL MANAGEMENT OF PAIN, EXPOSURE OR EXTRUSION FOLLOWING A SUBURETHRAL TAPE INSERTION FOR URINARY STRESS INCONTINENCE" WAS WRITTEN BY G. AGNEW PUBLISHED IN INT UROGYNECOL J (2014) 25:235-239. THIS ARTICLE IS FOR A RETROSPECTIVE REVIEW OF 47 CONSECUTIVE WOMEN WHO UNDERWENT SURGICAL REVISION FOR THE INDICATIONS OF PAIN, TAPE EXPOSURE OR TAPE EXTRUSION. TWO OF THESE PATIENTS HAD IVS IMPLANTED IN THE ORIGINAL PROCEDURE AND SUBSEQUENTLY HAD IT REMOVED FOR PAIN. THERE WAS RESOLUTION OF PAIN AFTER SURGICAL REVISION. AT THE REVISION OR HISTOLOGY, INFECTION WAS NOTED FOR ONE OF THESE TWO PATIENTS WHO HAD IVS IMPLANTED. THIS IS FOR THE PATIENT WHO UNDERWENT A REOPERATION FOR REMOVAL SECONDARY TO PAIN AND AT THE REVISION/HISTOLOGY INFECTION WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435361 UNKNOWN IVS TUNNELLER DEVICE NONE FTL BALLYMONEY - USS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other