BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMS PERIGEE SYSTEM WITH INTEPRO

    MDR report key: 5070201 · Received September 11, 2015

    Report

    Report Number
    2183959-2015-59401
    Event Type
    Death
    Date Received
    September 11, 2015
    Report Date
    August 23, 2015
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    OTP
    PMA / PMN Number
    K082387
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    LAWYER-FILED REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF ALLEGEDLY EXPERIENCED PAIN AND RECURRENCE OF SYMPTOMS. FURTHERMORE, IT WAS REPORTED THAT THE PLAINTIFF DIED. NO CAUSE OF DEATH WAS REPORTED. RELATED TO MANUFACTURER REPORT #: 2183959-2015-59395; RELATED TO MANUFACTURER REPORT #: 2183959-2015-59406.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602505 AMS PERIGEE SYSTEM WITH INTEPRO MESH, SURGICAL, POLYMERIC OTP AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death MONARC