BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-QUR V-PATCH

    MDR report key: 3875024 · Received June 2, 2014

    Report

    Report Number
    1219977-2014-00169
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    March 11, 2014
    Report Date
    May 6, 2014
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    FTL
    PMA / PMN Number
    K090909
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN OUTSIDE CLINICIAN WAS CONSULTED ON THIS EVENT. HIS OPINION WAS THAT THE INFECTION WAS LIKELY DUE TO: LACK OF PROPHYLACTIC ANTIBIOTIC USE, ERROR IN TECHNIQUE, ERROR IN PERIOPERATIVE HANDLING OF MESH, UNSTERILE INSTRUMENTATION, LATENT INFECTION IN OPERATIVE FIELD OF PT, POOR WOUND HEALING, PT NON-COMPLIANCE WITH WOUND CARE INSTRUCTIONS. EVEN IN CLEAN WOUND CLASSES, THERE WILL BE A 1-2% INCIDENCE OF INFECTION. A REVIEW WAS PERFORMED ON MFG AND STERILIZATION RECORDS AND NO PROBLEMS WERE NOTED. MDR 1219977-2014-00170, 00171.

    Description of Event or Problem · 1

    THE PT HAD MESH IMPLANTED FOR AN UMBILICAL HERNIA 2-6CM IN SIZE AT THE MIDLINE. THE MESH WAS PLACED RETRO-RECTUS (BEHIND THE MUSCLE) WITH PERMANENT SUTURES. AN INFECTION PRESENTED SEVERAL WEEKS AFTER THE MESH WAS IMPLANTED, AND THE MESH WAS REMOVED. DEEP TISSUE WAS CULTURED AND DETERMINED TO BE INFECTED. THE MESH WAS NOT TESTED FOR INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322044 C-QUR V-PATCH MESH, SURGICAL, POLYMERIC FTL ATRIUM MEDICAL CORPORATION 31201 10905924

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention