BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS INTEXEN-PORCINE DERMIS

    MDR report key: 5440215 · Received February 16, 2016

    Report

    Report Number
    3011770902-2015-10308
    Event Type
    Injury
    Date Received
    February 16, 2016
    Report Date
    November 16, 2015
    Manufacturer
    ASTORA WOMEN'S HEALTH, LLC
    Product Code
    OTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION-E2013032. TOTAL NUMBER OF EVENTS SUMMARIZED - 15. AMS INTEXEN-PORCINE DERMIS - 15 - ATTACHMENT: [PROCODEWISE SUMMARY REPORT -PAI - FEBRUARY 2016 SUBMISSION.XLS].

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF EXPERIENCED AN UNSPECIFIED INJURY. 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
    95875 AMS INTEXEN-PORCINE DERMIS NA OTO ASTORA WOMEN'S HEALTH, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability