BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APOGEE SYSTEM

    MDR report key: 3213560 · Received July 3, 2013

    Report

    Report Number
    2183959-2013-00918
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    December 3, 2011
    Report Date
    June 21, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS EVENT IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    RELATED TO MFR REPORT #2183959-2012-00919. IT WAS REPORTED THE PT WAS IMPLANTED WITH A APOGEE VAGINAL MESH AND MONARC VAGINAL SLING IN (B)(6) 2010. AFTER IMPLANTATION, THE PT EXPERIENCED PAIN, INCONTINENCE, AND LOSS OF BOWEL FUNCTION. THE REPORTER STATED, "PIECES OF PLASTIC MESH PROTRUDED FROM MY VAGINAL WALL. THERE WAS A FOUL ODOR COMING FROM MY VAGINA AND MY STOMACH WAS EXTENDED TO TWICE IT'S PRE SURGERY SIZE". SURGERY WAS PERFORMED TO REMOVE THE MESH AND SLING, IT WAS NOTED BY THE SURGEONS ACCORDING TO THE REPORTER THAT THE MESH WAS "EXTREMELY TIGHT" WHEN IT WAS CUT FOR REMOVAL. SCAR TISSUES WAS OBSERVED IN THE POSTERIOR VAGINAL SEPTUM, APEX OF THE VAGINA, AND THE AREA OF WHERE THE SLING WAS ORIGINALLY LOCATED. IT WAS ALSO NOTED, "THE SLING WAS LOOSE AND COMPLETELY NON-SUPPORTIVE OF THE URETHRA." NO ADD'L COMPLICATIONS HAVE BEEN REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305939 APOGEE SYSTEM SURGICAL MESH, POLYMERIC FTL AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R