BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS PERIGEE SYSTEM

    MDR report key: 5369499 · Received January 15, 2016

    Report

    Report Number
    3011770902-2016-00031
    Event Type
    Injury
    Date Received
    January 15, 2016
    Report Date
    January 12, 2016
    Manufacturer
    ASTORA WOMEN'S HEALTH LLC
    Product Code
    OTP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING THE IMPLANTATION OF A PERIGEE, THE PATIENT EXPERIENCED MESH EXPOSURE ALONG INCISION SITE, IN ADDITION TO GRANULATION OF THE TISSUE. THE PATIENT WAS ASYMPTOMATIC. THE GRANULATED TISSUE WAS REMOVED (B)(6) 2014, UNEVENTFULLY, WITH 0.1 CM3 MESH REMOVED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28897 AMS PERIGEE SYSTEM SURGICAL MESH OTP ASTORA WOMEN'S HEALTH LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention