BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLITE ULTRA MESH

    MDR report key: 4792712 · Received May 21, 2015

    Report

    Report Number
    1219977-2015-00152
    Event Type
    Injury
    Date Received
    May 21, 2015
    Date of Event
    December 21, 2009
    Report Date
    May 19, 2015
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    FTL
    PMA / PMN Number
    K002093
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION INTO THIS EVENT.

    Description of Event or Problem · 1

    RECEIVED A MEDWATCH STATING THAT A PT HAS A MESH IMPLANTED FOR INGUINAL HERNIA AND EXPERIENCED CHRONIC PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331646 PROLITE ULTRA MESH FTL ATRIUM MEDICAL CORP. 30702 10477745

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention