BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CQUR V PATCH

    MDR report key: 3020542 · Received March 21, 2013

    Report

    Report Number
    1219977-2013-00022
    Event Type
    Injury
    Date Received
    March 21, 2013
    Date of Event
    February 22, 2013
    Report Date
    March 1, 2013
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    FTL
    PMA / PMN Number
    K080688
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IN THE PROCESS OF PERFORMING AN EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS, INCLUDING THE STERILIZATION RECORDS, INDICATED THAT THE MESH WAS PROCESSED AND INSPECTED ACCORDING TO PROCEDURES AND NO DEVIATIONS WERE FOUND. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    PHYSICIAN PLACED A V PATCH WITH 2 PROLENE SUTURES AND CLOSED THE FASCIA OVER THE TOP. PT CAME BACK POST OP AFTER 2 WEEKS, BAD TISSUE GRANULATION, REDNESS, NO TISSUE INCORPORATION. TESTED, NO INFECTION, SURGEON DECIDED TO REMOVE DUE TO LACK OF HEALING AND INCORPORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116937 CQUR V PATCH FTL ATRIUM MEDICAL CORP. 31201 10741354

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention