BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIM KNOTLESS INCONTINENCE SLING

    MDR report key: 10301497 · Received July 20, 2020

    Report

    Report Number
    MW5095618
    Event Type
    Injury
    Date Received
    July 20, 2020
    Date of Event
    February 4, 2020
    Report Date
    July 16, 2020
    Manufacturer
    NEOMEDIC INTERNATIONAL
    Product Code
    OTN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD A KIM KNOTLESS INCONTINENCE SLING PUT IN AND 7 WEEKS LATER SUFFERED URINARY URGENCY FREQUENCY, A STUCK PAIN SENSATION AT URETHRA , PAIN AT URETHRA, PAINFUL INTERCOURSE, RASHES, HAIR LOSS, AND MORE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757980 KIM KNOTLESS INCONTINENCE SLING MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN NEOMEDIC INTERNATIONAL 190626

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R| S