BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL 2CM X 7XM 1.0MM

    MDR report key: 3131357 · Received May 20, 2013

    Report

    Report Number
    9617613-2013-00273
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    October 19, 2004
    Report Date
    June 22, 2018
    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
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: PELVIC ORGAN PROLAPSE. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. BIOARC TO SUBFASCIAL HAMMOCK WAS REPORTED TO BE USED/IMPLANTED DURING THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223447 PELVICOL 2CM X 7XM 1.0MM PELVICOL MESH FTL COVIDIEN, FORMERLY TISSUE SCIENCE 03B15

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Other