BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUPPORT PP KIT X1

    MDR report key: 5778660 · Received July 8, 2016

    Report

    Report Number
    9615742-2016-00083
    Event Type
    Injury
    Date Received
    July 8, 2016
    Date of Event
    December 3, 2004
    Report Date
    June 22, 2016
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OTN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE NUMBER: (B)(4). EXEMPTION NUMBER: E2013003. COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF C.R. BARD, INC., (IMPORTER). BARD'S TRACKING NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    REFERENCE NUMBER: (B)(4). EXEMPTION NUMBER: E2013003. COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF C.R. BARD, INC., (IMPORTER). BARD¿S TRACKING NUMBER: (B)(4).

    Description of Event or Problem · 0

    THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT.

    Description of Event or Problem · 0

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED PAIN, INFECTION, UNSPECIFIED URINARY PROBLEMS, AND RECURRENCE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE PATIENT ALLEGED EXPERIENCING AN UNSPECIFIED ADVERSE EVENT AS A RESULT OF THE DEVICE IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433123 URETEX SUPPORT PP KIT X1 MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN SOFRADIM PRODUCTION URETEXSUP

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention