BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL 4 X 12 CM

    MDR report key: 3250752 · Received July 19, 2013

    Report

    Report Number
    9617613-2013-00574
    Event Type
    Injury
    Date Received
    July 19, 2013
    Date of Event
    June 24, 2003
    Report Date
    May 8, 2018
    Manufacturer
    COVIDIEN, FORMERLY TISSUE
    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 TYPE: STRESS UI/PELVIC ORGAN PROLAPSE. ACCORDING TO THE RPTR: THE PT ALLEGED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339164 PELVICOL 4 X 12 CM PELVICOL MESH FTL COVIDIEN, FORMERLY TISSUE 02A23

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Other