BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUPPORT PP KIT X1

    MDR report key: 3131329 · Received May 17, 2013

    Report

    Report Number
    9615742-2013-00436
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    July 20, 2005
    Report Date
    June 17, 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

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PROCEDURE TYPE: STRESS URINARY INCONTINENCE. ACCORDING TO THE REPORTER: THE PT ALLEGED INJURY.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE PATIENT ALLEGED INJURY. THE INDICATION FOR IMPLANTATION OF TRANSVAGINAL MESH IN THIS PATIENT WAS STRESS INCONTINENCE AND URGE INCONTINENCE. PROCEDURE: UNDERWENT SLING (USING URETEX) PROCEDURE AND CYSTOSCOPY UNDER GENERAL ANESTHESIA. COMPLICATIONS POST IMPLANTATION: BLOATING, CONSTIPATION NAUSEA, AND LOWER ABDOMINAL DISCOMFORT AND ASSESSED WITH PARTIAL SMALL BOWEL OBSTRUCTION SECONDARY TO INTESTINAL ADHESIONS. ADDITIONAL SURGERY: (B)(6) 2005: UNDERWENT LAPAROSCOPIC LYSIS OF INTESTINAL ADHESIONS FOR SMALL BOWEL OBSTRUCTION AND INTESTINAL ADHESIONS UNDER GENERAL ENDOTRACHEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220408 URETEX SUPPORT PP KIT X1 URETEX SUPPORT OTN SOFRADIM PRODUCTION

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other