BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL 2CM X 7CM 1.0MM

    MDR report key: 3541303 · Received December 18, 2013

    Report

    Report Number
    9617613-2013-01647
    Event Type
    Injury
    Date Received
    December 18, 2013
    Date of Event
    October 5, 2007
    Report Date
    December 16, 2013
    Manufacturer
    COVIDIEN, FORMERLYTISSUE SCIENCE LABORATORIES, PLC
    Product Code
    FTL
    PMA / PMN Number
    K992556
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: STRESS UI / PELVIC ORGAN PROLAPSE. ACCORDING TO THE REPORTER: THE PT ALLEGED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661290 PELVICOL 2CM X 7CM 1.0MM PELVICOL MESH FTL COVIDIEN, FORMERLYTISSUE SCIENCE LABORATORIES, PLC 06B21-9

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other