BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEEDLELESS SLING

    MDR report key: 10141674 · Received June 11, 2020

    Report

    Report Number
    3006621295-2020-00004
    Event Type
    Injury
    Date Received
    June 11, 2020
    Date of Event
    September 9, 2015
    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 NEEDLELESS SLING IMPLANT, THE PATIENT PRESENTED EROSION OF THE VAGINAL MUCOSA AND RECURRENCE OF THE URINARY INCONTINENCE. IT WAS COMMUNICATED THAT THE PATIENT DID NOT WANT TO UNDERGO SURGICAL INTERVENTION TO REMOVE THE ERODED AREA OF THE SLING. LOCAL ESTROGEN WAS ADMINISTERED TO THE PATIENT. THE PATIENT EXPERIENCED PAIN, VAGINAL DISCHARGE AND RECURRENT STRESS URINARY INCONTINENCE THAT WAS PARTIALLY TREATED WITH BULKING AGENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606402 NEEDLELESS SLING SURGICAL MESH FOR STRESS URINARY INCONTINENCE PAH DIMA S.L. NL-01 CNL20081024

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention