BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL 2CM 2 7 CM 1.0MM

    MDR report key: 2944119 · Received January 17, 2013

    Report

    Report Number
    9617613-2013-00005
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 19, 2005
    Report Date
    May 31, 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). ADDITIONAL INFORMATION FROM USER FACILITY REPORT: DATE OF THIS REPORT: (B)(4) 2012, (B)(6).

    Description of Event or Problem · 1

    PROCEDURE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25730 PELVICOL 2CM 2 7 CM 1.0MM PELVICOL MESH FTL COVIDIEN, FORMERLY TISSUE NA 04B17-1

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Other