BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H10 COMMENTS

    MDR report key: 2890759 · Received December 21, 2012

    Report

    Report Number
    2183959-2012-03403
    Event Type
    Injury
    Date Received
    December 21, 2012
    Report Date
    November 15, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNK WHICH AMS PELVIC MESH PRODUCT WAS IMPLANTED. SHOULD ADD'L INFO BECOME AVAILABLE REGARDING THIS EVENT IT WILL BE RE-EVALUATED AND A F/U REPORT WILL BE SENT AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF EXPERIENCED AND UNSPECIFIED INJURY AND A PROBLEM WITH THE PRODUCT. RELATED TO MFR REPORT # 2183959-2012-03404.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEE H10 COMMENTS SURGICAL MESH FTL AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability UNK PELVIC MESH PRODUCT| UNK PELVIC MESH PRODUCT