BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL (BARD) 8CM X 12CM

    MDR report key: 3143144 · Received May 24, 2013

    Report

    Report Number
    9617613-2013-00293
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    March 25, 2009
    Report Date
    May 17, 2018
    Manufacturer
    COVIDIEN, FORMERLY TISSUE
    Product Code
    FTL
    PMA / PMN Number
    K992556
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230950 PELVICOL (BARD) 8CM X 12CM PELVICOL MESH FTL COVIDIEN, FORMERLY TISSUE 08B04-1

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Other