BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMS BIO ARC PRE-CONNECTED COLLAGEN DERMAL

    MDR report key: 4886469 · Received June 29, 2015

    Report

    Report Number
    2183959-2014-68234
    Event Type
    Death
    Date Received
    June 29, 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 Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS WAS INITIALLY SUBMITTED ON THE SUMMARY REPORT DATED (B)(6) 2014 UNDER EXEMPTION (B)(4). ADDITIONALLY THIS WAS SUBMITTED ON THE SUMMARY REPORT DATED (B)(6) 2015 UNDER EXEMPTION (B)(4). LAWYER-FILED REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF ALLEGEDLY EXPERIENCED AN UNSPECIFIED INJURY AND A PRODUCT PROBLEM. FURTHERMORE, IT WAS REPORTED THAT THE PLAINTIFF DIED. THE CAUSE OF DEATH WAS REPORTED AS ARTERIOSCLEROTIC CARDIOVASCULAR DISEASE. RELATED TO MFR REPORT # 2183959-2014-68233.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419163 AMS BIO ARC PRE-CONNECTED COLLAGEN DERMAL MESH, SURGICAL, POLYMERIC OTN AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death INTEPRO | PERIGEE SYSTEM| INTEPRO| PERIGEE SYSTEM