BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH, SURGICAL, POLYMERIC

    MDR report key: 2122904 · Received June 14, 2011

    Report

    Report Number
    3005099803-2011-01994
    Event Type
    Injury
    Date Received
    June 14, 2011
    Report Date
    May 20, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SLING SYSTEM (EXACT TYPE UNKNOWN) WAS USED DURING A TRANSVAGINAL BLADDER MESH PROCEDURE ON (B)(6) 2009. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED CONSTANT BLEEDING, INFECTIONS, PAIN AND DISCOMFORT SINCE THE INITIAL PROCEDURE. IT WAS REPORTED THAT THE MESH HAD ERODED AND THAT THE PATIENT HAD TWO SURGICAL REVISIONS TO REMOVE THE ERODED MESH. THE AMOUNT OF MESH EXCISED IS UNKNOWN. THE FIRST REVISION SURGERY WAS IN 2010 AND THE SECOND WAS IN 2011 (EXACT DATES UNKNOWN). THE PATIENT'S CURRENT CONDITION IS UNKNOWN AND REPORTEDLY UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK677

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention