BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-QUR TRACSHIELD

    MDR report key: 4381521 · Received December 31, 2014

    Report

    Report Number
    1219977-2014-00405
    Event Type
    Injury
    Date Received
    December 31, 2014
    Report Date
    December 17, 2014
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    FTL
    PMA / PMN Number
    K100076
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL PRODUCT WAS NOT RETURNED AND THERE WERE NEITHER PRODUCT CODE, DESCRIPTION OR PRODUCT LOT NUMBER PROVIDED, THE COMPLAINT COULD NOT BE FULLY INVESTIGATED. SEVERAL ATTEMPTS WERE MADE TO COLLECT ADDITIONAL DETAILS WITHOUT ANY SUCCESS. THE MESH PRODUCT IS PROVIDED STERILE TO THE USER. THE PRODUCT IS STERILIZED USING A TRADITIONAL 3-STEP ETHYLENE OXIDE (EO) CYCLE THAT DELIVERS A 10-6 STERILITY ASSURANCE LEVEL (SAL). THIS CYCLE IS VALIDATED USING BIOLOGICAL INDICATORS (BIS) PER THE 'OVERKILL METHOD' OUTLINED IN ANSI/AAMI/ISO 11135-1:2007, STERILIZATION OF HEALTH CARE PRODUCTS. RELATED MDR'S 1219977-2014-00406 AND 00407.

    Description of Event or Problem · 1

    A HOSPITAL REPORTED THREE INFECTION CASES FOLLOWING HERNIA REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863112 C-QUR TRACSHIELD MESH, SURGICAL, POLYMERIC FTL ATRIUM MEDICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention