BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PELVICOL PRODUCT

    MDR report key: 2990041 · Received February 21, 2013

    Report

    Report Number
    9617613-2013-00053
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    June 15, 2006
    Report Date
    January 25, 2013
    Manufacturer
    COVIDIEN, FORMERLY TISSUE SCIENCE
    Product Code
    FTL
    PMA / PMN Number
    K992556
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. ADD'L INFO FROM IMPORTER REPORT 1018233-2013-00452: ADD'L INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75316 UNKNOWN PELVICOL PRODUCT PELVICOL MESH FTL COVIDIEN, FORMERLY TISSUE SCIENCE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other| R