BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMS BIO ARC PRE-CONNECTED COLLAGEN DERMAL

    MDR report key: 4817657 · Received June 2, 2015

    Report

    Report Number
    2183959-2014-68013
    Event Type
    Death
    Date Received
    June 2, 2015
    Report Date
    September 23, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    OTN
    PMA / PMN Number
    K030123
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS WAS INITIALLY REPORTED ON THE SUMMARY REPORT DATED (B)(6) 2014 UNDER EXEMPTION (B)(4). LAWYER-FILED REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF EXPERIENCED AN UNSPECIFIED INJURY. FURTHERMORE, IT WAS REPORTED THAT THE PLAINTIFF DIED. THE CAUSE OF DEATH REPORTED WERE RESPIRATORY FAILURE, PLEURAL EFFUSION AND CHOLANGIO CARCINOMA WITH METASTASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356686 AMS BIO ARC PRE-CONNECTED COLLAGEN DERMAL MESH, SURGICAL, POLYMERIC OTN AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death