BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL (BARD) 8CM X 12 CM

    MDR report key: 3231934 · Received July 11, 2013

    Report

    Report Number
    9617613-2013-00489
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    August 17, 2004
    Report Date
    June 17, 2013
    Manufacturer
    COVIDIEN
    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

    TRACKING NUMBER: (B)(4) 2013.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE PATIENT ALLEGED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319766 PELVICOL (BARD) 8CM X 12 CM PELVICOL MESH FTL COVIDIEN 04B10-1

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other URETEXSUP, URETEX SUPPORT PP KIT X1:| LOT NUMBER: C24082SUP, EXP: 03/31/2009