BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTASURE

    MDR report key: 2004011 · Received February 23, 2011

    Report

    Report Number
    MW5019571
    Event Type
    Injury
    Date Received
    February 23, 2011
    Date of Event
    January 4, 2011
    Report Date
    February 23, 2011
    Manufacturer
    NEOMEDIC INTL S.L.
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PLACEMENT OF THE CONTASURE MESH SLING IMPLANT CAUSED DYSPAREUNIA, DYSURIA, RECURRENT URINARY TRACT INFECTIONS AND PELVIC PAIN IMMEDIATELY AFTER IMPLANTATION. CLINICAL EXAM FOUND THE MESH ERODED THROUGH THE ANTERIOR VAGINA. CYSTOSCOPY AT THE TIME OF EXPLANTATION SHOWED THE MESH HAD PERFORATED THE LEFT LATERAL BLADDER BASE AND A LARGE PORTION OF THE MESH WAS IN THE BLADDER. DIAGNOSIS OR REASON FOR USE: URINARY INCONTINENCE. EVENT NOT ABATED AFTER USE STOPPED OR DOSE REDUCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTASURE CONTASURE NEEDLELESS SYSTEM FTL NEOMEDIC INTL S.L. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization