BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL 6 X 8 CM

    MDR report key: 3212778 · Received July 1, 2013

    Report

    Report Number
    9617613-2013-00414
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    October 9, 2002
    Report Date
    April 1, 2018
    Manufacturer
    COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES
    Product Code
    FTL
    PMA / PMN Number
    K992556
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT ALLEGED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297544 PELVICOL 6 X 8 CM PELVICOL MESH FTL COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES 01A24

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Other 482212 PELVICOL ACELLULAR COLLIGEN MATRIX 2X12CM, LOT# 02A13, SERIAL # (B)(4), EXP: 05/22/2003