BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERIGEE SYSTEM

    MDR report key: 2940564 · Received January 30, 2013

    Report

    Report Number
    2183959-2013-00489
    Event Type
    Injury
    Date Received
    January 30, 2013
    Report Date
    January 7, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE: REISENAUER C., VIRECK V, MESH-RELATED COMPLICATIONS IN UROGYNECOLOGY - A MULTIDISCIPLINARY CHALLENGE. ACTA OBSTET GYNECOL SCAND 2012;91:869-872. SHOULD ADDITIONAL INFO BECOME AVAILABLE REGARDING THIS EVENT IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) WOMAN WITH UTERINE PROLAPSE AND CYSTOCELE WAS TREATED WITH VAGINAL HYSTERECTOMY AND A PERIGEE DEVICE. ADDITIONAL INFO PROVIDED INDICATES THAT THE PT SUFFERED FROM VAGINAL DISCHARGE FOR ONE YEAR FOLLOWING SURGERY, IN SPITE OF LOCAL AND SYSTEMIC ANTIBIOTIC THERAPIES AND LOCAL ANTISEPTIC THERAPIES. THE EXAMINATION REVEALED MESH EROSION (EXPOSURE) WITH SIGNS OF INFECTION. AFTER EXCISION OF THE ERODED PART OF THE MESH, THE WOUND HEALED WITHOUT PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40712 PERIGEE SYSTEM SURGICAL MESH FTL AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| R