BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLITE MESH

    MDR report key: 3875141 · Received May 1, 2014

    Report

    Report Number
    1219977-2014-00145
    Event Type
    Injury
    Date Received
    May 1, 2014
    Report Date
    April 13, 2014
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    FTL
    PMA / PMN Number
    K930669
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A THOROUGH INVESTIGATION WAS NOT ABLE TO BE PERFORMED AS NO PRODUCT CODE, LOT NUMBER, OR SAMPLE WAS PROVIDED. A REVIEW OF COMPLAINT WAS PERFORMED AND THERE HAVE NOT BEEN ANY SIMILAR REPORTS RELATED TO A DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    THIS EVENT IS DEEMED REPORTABLE BASED ON THE ALLEGATIONS IN A LAWSUIT WHICH, WHILE UNSUBSTANTIATED, SUGGEST THAT A REPORTABLE EVENT MAY HAVE OCCURRED DURING USE OF ATRIUM MEDICALS MESH PRODUCT. PLAINTIFF ALLEGES SHE HAD MESH IMPLANTED FOR TRANSVAGINAL PROCEDURE. PLAINTIFF ALLEGES INJURIES AS A RESULT OF THE IMPLANTATION. 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 COMES TO ITS ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261011 PROLITE MESH FTL ATRIUM MEDICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other