BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PELVICOL PRODUCT

    MDR report key: 6117657 · Received November 21, 2016

    Report

    Report Number
    9617613-2016-00098
    Event Type
    Injury
    Date Received
    November 21, 2016
    Date of Event
    January 28, 2008
    Report Date
    October 26, 2016
    Manufacturer
    COVIDIEN, FORMERLY TISSUE SCIENCE LABOR
    Product Code
    FTL
    PMA / PMN Number
    K992556
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769755 UNKNOWN PELVICOL PRODUCT MESH, SURGICAL, POLYMERIC FTL COVIDIEN, FORMERLY TISSUE SCIENCE LABOR

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other