BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL 2 X 20 CM

    MDR report key: 3220964 · Received July 3, 2013

    Report

    Report Number
    9617613-2013-00426
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    May 14, 2002
    Report Date
    June 27, 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: STRESS UI/PELVIC ORGAN PROLAPSE. ACCORDING TO THE REPORTER: THE PT ALLEGED INJURY. MEDICAL HISTORY: VAGINAL VAULT PROLAPSE, VAGINAL ATROPHY, USI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303656 PELVICOL 2 X 20 CM PELVICOL MESH FTL COVIDIEN, FORMERLY TISSUE 01A19

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female 482027 PELVICOL 2CM X 7CM 1.0MM, LOT 01A20, SERIAL# (B)(4), EXP: 10/16/2002, MFR DATE: 10/2001.