BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX MESH PRODUCT

    MDR report key: 3952011 · Received July 15, 2014

    Report

    Report Number
    9615742-2014-00227
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    July 24, 2006
    Report Date
    July 2, 2014
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OTN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4), (IMPORTER).

    Description of Event or Problem · 1

    PROCEDURE: STRESS URINARY INCONTINENCE/PELVIC ORGAN PROLAPSE. ACCORDING TO THE REPORTER: THE PATIENT ALLEGED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412939 URETEX MESH PRODUCT URETEX MESH OTN SOFRADIM PRODUCTION

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other