BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLITE ULTRA MESH

    MDR report key: 3761003 · Received April 11, 2014

    Report

    Report Number
    1219977-2014-00112
    Event Type
    Injury
    Date Received
    April 11, 2014
    Date of Event
    February 20, 2007
    Report Date
    August 6, 2012
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    FTL
    PMA / PMN Number
    K002093
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF MANUFACTURING AND STERILIZATION RECORDS WAS PERFORMED AND THERE WAS NOT ANY PROBLEMS NOTED THAT WOULD IMPACT THIS REPORT. A REVIEW OF COMPLAINTS WAS PERFORMED AND THERE HAVE NOT BEEN ANY SIMILAR REPORTS RELATED TO A DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    THIS REPORT IS DEEMED REPORTABLE BASED ON THE ALLEGATIONS IN A RESULT WHICH, WHILE UNSUBSTANTIATED, SUGGEST THAT A REPORTABLE EVENT MAY HAVE OCCURRED DURING USE OF ATRIUM MEDICALS MESH PRODUCT. THE PLAINTIFF ALLEGES SLING MESH WAS IMPLANTED WITH THE INTENTION OF TREATING HER FOR URINARY INCONTINENCE BUT THE MESH HAD ERODED INTO HER VAGINA. PLAINTIFF ALLEGES SHE HAD PAIN AND HAD SURGICAL PROCEDURES IN ATTEMPT TO REPAIR THE MESH. THE ATTEMPT TO REPAIR THE MESH HAVE BEEN UNSUCCESSFUL. SINCE THIS IS A LEGAL MATTER, THE CASE HAS BEEN TURNED OVER TO LEGAL COUNSEL AND FURTHER INFO 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 INFO BECOMES TO ITS ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221212 PROLITE ULTRA MESH FTL ATRIUM MEDICAL CORP. 1000212-00 10064310

    Patients

    Seq Age Sex Outcome Treatment
    1 Other