BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS APOGEE SYSTEM WITH PC COATED INTEPRO LITE

    MDR report key: 3901502 · Received June 30, 2014

    Report

    Report Number
    2183959-2014-17452
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    March 8, 2011
    Report Date
    April 18, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    OTP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TOTAL NUMBER OF EVENTS SUMMARIZED - (B)(4). AMS APOGEE PC WITH INTEXENLP - (B)(4). AMS APOGEE SYSTEM - (B)(4). AMS APOGEE SYSTEM WITH PC COATED INTEPRO LITE - (B)(4). AMS ELEVATE (NOT SPECIFIED) - (B)(4). AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE - (B)(4). AMS ELEVATE PC - 2. AMS ELEVATE PC ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE - (B)(4). AMS ELEVATE PC POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE - (B)(4). AMS ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE - (B)(4). AMS PERIGEE SYSTEM - (B)(4). AMS PERIGEE SYSTEM WITH INTEPRO - (B)(4). AMS PERIGEE SYSTEM WITH PC COATED INTEPRO LITE - (B)(4). UNKNOWN GRAFT MESH - (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF EXPERIENCED VAGINAL BLEEDING AND NONHEALING MESH WITH EXTRUSION ON (B)(6) 2011. FURTHERMORE, IT WAS ALSO REPORTED THAT THE PLAINTIFF ALLEGEDLY EXPERIENCED EMOTIONAL DISTRESS AND A PRODUCT PROBLEM. THE PLAINTIFF UNDERWENT SERIES OF MESH REVISIONS AND IMPLANTATION OF ANOTHER DEVICE ON (B)(6) 2011 TO (B)(6) 2013. THE MESH REMAINS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379025 AMS APOGEE SYSTEM WITH PC COATED INTEPRO LITE MESH, SURGICAL, POLYMERIC OTP AMERICAN MEDICAL SYSTEMS 720002-01

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R| S ETHICON PROLENE SOFT| ETHICON PROLENE SOFT