BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEEDLELESS SLING

    MDR report key: 10141672 · Received June 11, 2020

    Report

    Report Number
    3006621295-2020-00003
    Event Type
    Injury
    Date Received
    June 11, 2020
    Date of Event
    March 17, 2010
    Report Date
    June 10, 2020
    Manufacturer
    DIMA S.L.
    Product Code
    PAH
    PMA / PMN Number
    K063136
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS COMMUNICATED THAT THE PATIENT UNDERWENT ANOTHER INCONTINENCE OPERATION AT A DIFFERENT HOSPITAL AND HAD ANOTHER MESH SLING IMPLANTED (TVT-O). IT WAS ALSO REPORTED THAT AFTER A PERIOD OF TIME, THE PATIENT RETURNED TO THE FIRST HOSPITAL CLAIMING THAT HER HUSBAND EXPERIENCED DISCOMFORT; IT WAS FOUND THAT THE MESH WAS SHOWING AT THE VAGINAL WALL. PART OF THE MESH WAS EXCISED. IT WAS REPORTED THAT THE CURRENT SITUATION IS THAT THERE IS NO MESH AT THE VAGINAL MUCOSA AND THE PATIENT IS BETTER BUT NOT FULLY CONTINENT.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT SURGICAL INTERVENTION AND SOME WEEKS AFTER THE OPERATION, PART OF THE MESH EXTRUDED INTO THE VAGINAL MUCOSA. THE EXTRUSION WAS REPAIRED BY SUTURING THE MUCOSA OVER THE MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606404 NEEDLELESS SLING SURGICAL MESH FOR STRESS URINARY INCONTINENCE PAH DIMA S.L. NL-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention