BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPARC SLING SYSTEM

    MDR report key: 378562 · Received February 21, 2002

    Report

    Report Number
    2183959-2002-00012
    Event Type
    Injury
    Date Received
    February 21, 2002
    Date of Event
    February 7, 2002
    Report Date
    February 21, 2002
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FHK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AFTER 3 MONTHS PATIENT SHOWED SIGNS OF VAGINAL EROSION, FROM THE OUTSIDE VAGINAL AREA TO THE INSIDE. PATIENT SHOWED NO SIGNS OF STRESS INCONTINENCE. EXAM SHOWED EROSION WITH NO SIGNS OF INFECTION AND PAIN. DOCTOR DID A VAGINAL DISSECTION AROUND THE MESH. MESH WAS COVERED WITH VAGINAL TISSUE AT THE SITE OF THE EROSION. PROCEDURE TOOK 15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPARC SLING SYSTEM SPARC SLING SYSTEM FHK AMERICAN MEDICAL SYSTEMS, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R