BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERIGEE SYSTEM

    MDR report key: 2921839 · Received January 15, 2013

    Report

    Report Number
    2183959-2013-00273
    Event Type
    Injury
    Date Received
    January 15, 2013
    Date of Event
    December 15, 2011
    Report Date
    December 5, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    OTP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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 AS APPROPRIATE. LAWYER-FILED REPORT-(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF ALLEGEDLY EXPERIENCED EMOTIONAL DISTRESS, A PROBLEM WITH THE PRODUCT, AND REQUIRED AN ADDITIONAL SURGICAL PROCEDURE. RELATED TO MFR REPORT #2183959-2013-00272, 2183959-2013-00274.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23043 PERIGEE SYSTEM SURGICAL MESH OTP AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S APOGEE GRAFT| BIOARC SLING| GYNECARE TVT MESH | GYNECARE TVT MESH| BIOARC SLING| APOGEE GRAFT