BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CQUR MESH

    MDR report key: 3093621 · Received May 1, 2013

    Report

    Report Number
    1219977-2013-00051
    Event Type
    Injury
    Date Received
    May 1, 2013
    Date of Event
    March 31, 2013
    Report Date
    April 4, 2013
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    FTL
    PMA / PMN Number
    K050311
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IN PROCESS OF EVALUATING.

    Description of Event or Problem · 1

    PHYSICIAN INFORMED THE SALES REP THAT HE IMPLANTED CQUR MESH IN A LAP VENTRAL HERNIA REPAIR IN WHICH HE BRIDGED 3 SEPARATE DEFECTS. HE INFORMED SALES REP THAT THE PATIENT NOW HAS 3 RASHES (DERMATITIS) ON THE SKIN DIRECTLY OVER WHERE THE 3 DEFECTS WERE. HE TOLD THE SALES REP THAT THE PATIENT IS FINE. THERE IS NO FEVER, THE PATIENT'S WHITE COUNT IS FINE, AND THERE IS NO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190078 CQUR MESH FTL ATRIUM MEDICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other