BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-QUR MESH

    MDR report key: 3940323 · Received June 26, 2014

    Report

    Report Number
    1219977-2014-00190
    Event Type
    Injury
    Date Received
    June 26, 2014
    Date of Event
    February 1, 2014
    Report Date
    May 27, 2014
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    FTL
    PMA / PMN Number
    K050311
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION INTO THIS EVENT A FOLLOW UP REPORT WILL BE SUBMITTED. SINCE THIS IS A POTENTIAL LEGAL MATTER, THE CASE HAS BEEN TURNED OVER TO LEGAL COUNSEL AND FURTHER INFORMATION OBTAINED THROUGH INVESTIGATION OR DISCOVERY MAY FALL UNDER THE ATTORNEY/CLIENT AND/OR WORK PRODUCT PRIVILEGE. HOWEVER, ATRIUM WILL SUPPLEMENT THIS REPORT AS APPROPRIATE IF ADDITIONAL INFORMATION COMES TO ITS ATTENTION.

    Description of Event or Problem · 1

    THIS EVENT IS DEEMED REPORTABLE BASED ON THE ALLEGATIONS IN A POTENTIAL LAWSUIT WHICH, WHILE UNSUBSTANTIATED, SUGGEST THAT A REPORTABLE EVENT MAY HAVE OCCURRED DURING USE OF AN ATRIUM MEDICAL MESH PRODUCT. CLAIMANT ALLEGES THAT HE WAS IMPLANTED WITH A MESH PRODUCT AND HAD IT REMOVED DUE TO COMPLICATIONS: INFECTION, MESH-ROLL UP, PAIN, AND GALL BLADDER REMOVAL. SINCE THIS IS A POTENTIAL LEGAL MATTER, THE CASE HAS BEEN TURNED OVER TO LEGAL COUNSEL AND FURTHER INFORMATION OBTAINED THROUGH INVESTIGATION OR DISCOVERY MAY FALL UNDER THE ATTORNEY/CLIENT AND/OR WORK PRODUCT PRIVILEGE. HOWEVER, ATRIUM WILL SUPPLEMENT THIS REPORT AS APPROPRIATE IF ADDITIONAL INFORMATION COMES TO ITS ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373395 C-QUR MESH MSH, SURGICAL, POLYMERIC FTL ATRIUM MEDICAL CORP. 31533 10613812

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention