BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUPPORT PP KIT X1

    MDR report key: 3833429 · Received May 19, 2014

    Report

    Report Number
    9615742-2014-00166
    Event Type
    Injury
    Date Received
    May 19, 2014
    Date of Event
    November 6, 2003
    Report Date
    April 30, 2014
    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 (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE PATIENT ALLEGED INJURY. SHE HAS EXPERIENCED PAIN, RECURRENCE OF THE ORIGINAL PROBLEM, EROSION OF VAGINAL TISSUE AND MESH EROSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295459 URETEX SUPPORT PP KIT X1 URETEX SUPPORT OTN SOFRADIM PRODUCTION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Other