BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEEDLELESS SLING

    MDR report key: 10141670 · Received June 11, 2020

    Report

    Report Number
    3006621295-2020-00002
    Event Type
    Injury
    Date Received
    June 11, 2020
    Date of Event
    May 26, 2009
    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

    Description of Event or Problem · 1

    AFTER RECEIVING A NEEDLELESS SLING IMPLANT, THE PATIENT EXPERIENCED EROSION OF THE VAGINAL MUCOSA. PARTIAL EXPLANTATION WAS PERFORMED SUCCESSFULLY TO REMOVE THE PART OF THE MESH THAT HAD EXTRUDED INTO THE VAGINAL MUCOSA WITH NO FURTHER CONSEQUENCES (FOR EXAMPLE THERE WAS NO INFECTION OR ADDITIONAL DAMAGE TO THE PATIENT). PATIENT OUTCOME WAS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606346 NEEDLELESS SLING SURGICAL MESH FOR STRESS URINARY INCONTINENCE PAH DIMA S.L. NL-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention