BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLITE MESH

    MDR report key: 3761001 · Received April 11, 2014

    Report

    Report Number
    1219977-2014-00118
    Event Type
    Injury
    Date Received
    April 11, 2014
    Report Date
    June 28, 2013
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    FTL
    PMA / PMN Number
    K930669
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS AND STERILIZATION RECORDS WERE REVIEWED AND NO PROBLEMS WERE NOTED THAT WOULD IMPACT THIS EVENT. A REVIEW OF COMPLAINTS WAS CONDUCTED AND THERE HAVE BEEN NO SIMILAR REPORTS DUE TO A DEVICE FAILURE.

    Description of Event or Problem · 1

    THIS EVENT IS DEEMED REPORTABLE BASED ON THE ALLEGATIONS IN A POTENTIAL LAWSUIT WHICH, WHILE UNSUBSTANTIATED, SUGGESTS THAT A REPORTABLE EVENT MAY HAVE OCCURRED DURING USE OF ATRIUM MEDICAL MESH PRODUCT. PLAINTIFF ALLEGED THAT SHE HAD MESH IMPLANTED FOR MIXED INCONTINENCE AND CYSTOCELE. FOLLOWING IMPLANT, PLAINTIFF ALLEGED INJURIES, NOT LISTED. SINCE THIS IS A POTENTIAL LEGAL MATTER, THE CASE HAS BEEN TURNED OVER TO LEGAL COUNSEL AND FURTHER INFO OBTAINED THROUGH INVESTIGATION OR DISCOVERY MAY FALL UNDER THE ATTORNEY/PT AND/OR WORK PRODUCT PRIVILEGE. HOWEVER, ATRIUM WILL SUPPLEMENT THIS REPORT APPROPRIATE IF ADDITIONAL INFO COMES TO ITS ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220659 PROLITE MESH FTL ATRIUM MEDICAL CORP. 1000306-00 10161901

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention