BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-QUR V PATCH

    MDR report key: 4132570 · Received September 24, 2014

    Report

    Report Number
    1219977-2014-00324
    Event Type
    Injury
    Date Received
    September 24, 2014
    Report Date
    August 25, 2014
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    FTL
    PMA / PMN Number
    K090909
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE IN THE PROCESS OF PERFORMING THE INVESTIGATION AND WILL SUBMIT THE FOLLOW-UP REPORT ONCE THE EVAL IS COMPLETED.

    Description of Event or Problem · 1

    PT HAD MESH IMPLANTED FOR UMBILICAL HERNIA AND LATER PRESENTED AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596207 C-QUR V PATCH MESH, SURGICAL POLYMERIC FTL ATRIUM MEDICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1