BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERIGEE

    MDR report key: 2181322 · Received July 21, 2011

    Report

    Report Number
    2183959-2011-00272
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 7, 2011
    Manufacturer
    AMERICAN MEDICLA SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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

    IT WAS REPORTED THAT A PERIGEE MESH WAS IMPLANTED IN 2008 TO TREAT PELVIC ORGAN PROLAPSE. ANOTHER DEVICE WAS IMPLANTED TO TREAT URINARY INCONTINENCE. ABOUT ONE YEAR AFTER IMPLANT, THE PT BECAME SYMPTOMATIC WITH RECURRENT CYSTOCELE, BLADDER SYMPTOMS AND PAIN IN THE VAGINA AND IN THE RIGHT LOWER QUADRANT PAIN. THE ARMS OF THE PERIGEE COULD BE PALPATED, HOWEVER, THERE WAS NO PAIN ON VAGINAL EXAMINATION. THE PAIN WAS CAUSED BY THE INCONTINENCE DEVICE "PASSING THROUGH THE ABDOMINAL WALL AND PULLING THIS AREA," CAUSING PAIN. "THIS WAS ALSO AGGRAVATED BY THE RECURRENT PROLAPSE OR THE VAGINA AND PULLING ON THE OTHER MESH DEVICE. SURGICAL INTERVENTION INCLUDED REPAIR OF THE VAULT PROLAPSE WITH A "LAPAROSCOPIC MESH SACRALCOLPOPEXY," DISSECTION INTO THE RETROPUBIC SPACE AND IDENTIFYING THE OTHER MESH DEVICE THAT WAS PULLING ON THE ABDOMINAL WALL (FOUND TO BE IN THE INCORRECT POSITION) WITH RELEASE AND PARTIAL REMOVAL OF THAT MESH. THE PT RECOVERED WELL, HER PAIN RESOLVED AND VAGINAL SUPPORT WAS RESTORED. THE PT REMAINED CONTINENT AFTER SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S TVT SLING-2008