BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS INTEXEN-PORCINE DERMIS

    MDR report key: 3901378 · Received June 30, 2014

    Report

    Report Number
    2183959-2014-17602
    Event Type
    Injury
    Date Received
    June 30, 2014
    Report Date
    March 20, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    OTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF ALLEGEDLY EXPERIENCED PAIN, URINARY PROBLEMS, BOWEL PROBLEMS, RECURRENCE, AND DYSPAREUNIA. THE DEVICE REMAINS IMPLANTED. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380956 AMS INTEXEN-PORCINE DERMIS MESH, SURGICAL OTO AMERICAN MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability APOGEE SYSTEM WITH INTEPRO| BIOARC SUBFASCIAL HAMMOCK WITH TENSIONING SUTURE| APOGEE SYSTEM WITH INTEPRO| BIOARC SUBFASCIAL HAMMOCK WITH TENSIONING SUTURE