BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEXEN LP GRAFT, FGS

    MDR report key: 3030237 · Received March 28, 2013

    Report

    Report Number
    2183959-2013-00764
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    OTP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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

    RELATED TO MFR REPORT # 2183959-2012-00763. AN INTEXEN FGS GRAFT WAS IMPLANTED ON (B)(6) 2013. IT WAS REPORTED THAT THE PATIENT WAS SEEN AT 2 AND HALF WEEKS FOR FOLLOW UP AND THE VAGINAL WALLS APPEARED WHITE, INFLAMED AND DISCHARGE WAS OBSERVED. PATIENT'S TREATMENT IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128472 INTEXEN LP GRAFT, FGS SURGICAL MESH OTP AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability BIOARC SLING