BEUDAMED
    FDA Adverse Event Death Summary report: N

    PELVICOL 2CM X 7CM 1.0MM

    MDR report key: 3040377 · Received March 25, 2013

    Report

    Report Number
    9617613-2013-00117
    Event Type
    Death
    Date Received
    March 25, 2013
    Date of Event
    May 10, 2010
    Report Date
    June 20, 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
    ATTORNEY
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADD'L INFO FROM THE IMPORTER: (B)(6).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UROGYNECOLOGICAL. ACCORDING TO THE RPTR: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. ADD'L INFO HAS BEEN REQUESTED, BUT NOT YET REC'D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122157 PELVICOL 2CM X 7CM 1.0MM PELVICOL MESH FTL COVIDIEN, FORMERLY TISSUE NA 09B08-8

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Death| R| O