BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERIGEE

    MDR report key: 2247691 · Received September 8, 2011

    Report

    Report Number
    2183959-2011-00324
    Event Type
    Injury
    Date Received
    September 8, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 12, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFO BECOME AVAILABLE REGARDING THIS EVENT IT WILL BE RE-EVALUATED AND A F/U REPORT WILL BE SENT.

    Description of Event or Problem · 1

    RELATED TO MFR REPORT # 2183959-2010-00325. ON (B)(6) 2008, A BLADDER SUSPENSION PROCEDURE WAS DONE USING A SURGICAL MESH. "UPON INFO AND BELIEF, MESH IS MANUFACTURED BY DEFENDANT AMERICAN MEDICAL SYSTEMS, INC. AND IS CALLED AN APOGEE SYSTEM AND A PERIGEE SYSTEM." FOLLOWING SURGERY, THE PT ALLEGEDLY EXPERIENCED, "A GREAT DEAL OF PELVIC PAIN, URINARY INCONTINENCE, SHARP PAINS DURING URINATION AND CONTINUOUS INFECTIONS." ON (B)(6) 2008, "THE MESH AND STITCH WERE REMOVED FROM HER BLADDER IN MULTIPLE PIECES. THE SYNTHETIC MESH HAD ERODED INTO HER BLADDER." SHE "CONTINUED TO EXPERIENCE THE SAME PAINFUL SYMPTOMS AND PROBLEMS." SHE UNDERWENT ANOTHER SURGERY ON (B)(6) 2009, "TO REMOVE THE PREVIOUS GRAFT ARM", THEN WAS IMPLANTED WITH ANOTHER MESH DEVICE BY A DIFFERENT MFR. SHE, "CONTINUED STILL TO SUFFER WITH THE SAME PAINFUL SYMPTOMS AND PROBLEMS." ON (B)(6) 2010, SHE HAD A, "COMPLEX SURGERY" TO REMOVE MORE ERODED MESH AND CONTINUES TO EXPERIENCE, "THE SAME PAINFUL SYMPTOMS AND PROBLEMS."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention APOGEE GRAFT