BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERIGEE SYSTEM

    MDR report key: 2960234 · Received February 8, 2013

    Report

    Report Number
    2183959-2013-00642
    Event Type
    Injury
    Date Received
    February 8, 2013
    Report Date
    January 9, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    OTP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 EMOTIONAL DISTRESS AND A PROBLEM WITH THE PRODUCT. RELATED TO MFR REPORT #2183959-2013-00641 & -00643.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53424 PERIGEE SYSTEM SURGICAL MESH OTP AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability APOGEE| IMPLANTED:| IMPLANTED:| MONARC| IMPLANTED:| IMPLANTED:| APOGEE| MONARC