BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLITE MESH

    MDR report key: 2872326 · Received December 11, 2012

    Report

    Report Number
    1219977-2012-00033
    Event Type
    Injury
    Date Received
    December 11, 2012
    Date of Event
    April 12, 2012
    Report Date
    November 19, 2012
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE EVAL WAS PERFORMED SINCE THE DEVICE WAS NOT RETURNED TO THE MFR AND THE PRODUCT WAS NOT PROVIDED IN THE REPORT. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED SINCE THE PRODUCT LOT NUMBER WAS NOT PROVIDED IN THE REPORT. NO CONCLUSION CAN BE DRAWN. A F/U REPORT WILL BE SUBMITTED UPON RECEIPT OF ANY ADD'L INFO ON THE EVENT.

    Description of Event or Problem · 1

    RECEIVED MAUDE EVENT REPORT ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLITE MESH FTL ATRIUM MEDICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other