BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-QUR V-PATCH

    MDR report key: 3875003 · Received June 2, 2014

    Report

    Report Number
    1219977-2014-00170
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 6, 2014
    Manufacturer
    ATRIUM MEDICAL CORP.
    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 1219977-2014-00169, 00171.

    Description of Event or Problem · 1

    THE PT HAD MESH IMPLANTED FOR AN UMBILICAL HERNIA. THE MESH WAS TAKEN OUT DUE TO A PERCEIVED DEEP INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321944 C-QUR V-PATCH MESH, SURGICAL, POLYMERIC FTL ATRIUM MEDICAL CORP. 31202 200427

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention