BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUPPORT PP KIT XL

    MDR report key: 3424854 · Received October 18, 2013

    Report

    Report Number
    9615742-2013-02061
    Event Type
    Injury
    Date Received
    October 18, 2013
    Date of Event
    June 28, 2007
    Report Date
    December 12, 2018
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OTN
    PMA / PMN Number
    K012949
    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). COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF C.R. BARD, INC.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE PT ALLEGED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535803 URETEX SUPPORT PP KIT XL URETEX SUPPORT OTN SOFRADIM PRODUCTION SGE0018

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Other