BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUPPORT PP TRANSOBTUR2 KIT X1

    MDR report key: 3111709 · Received April 10, 2013

    Report

    Report Number
    9615742-2013-00247
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    December 29, 2008
    Report Date
    March 14, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OTN
    PMA / PMN Number
    K041176
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6).

    Description of Event or Problem · 1

    PROCEDURE TYPE: STRESS UI/PELVIC ORGAN PROLAPSE. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. AVAULTA SOLO ANTERIOR SYNTHETIC SUPPORT WAS REPORTED TO BE USED/IMPLANTED DURING THIS PROCEDURE.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED DYSPAREUNIA, VAGINAL PAIN, TENDERNESS, INCISIONAL PAIN, ABDOMINAL PAIN, PELVIC PAIN, HEMATURIA, "HOT" URINE, ABDOMINAL SWELLING, FREQUENCY, INCONTINENCE, BACK PAIN, ABNORMALITY OF URINATION, INCOMPLETE EMPTYING, URETHRAL STENOSIS, URGENCY, RECURRENT URINARY TRACT INFECTION, URINARY CALCULUS, DYSURIA, KENALOG INJECTIONS, PALPABLE MESH AND CYSTOSCOPY WITH URETHRAL DILATION. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT REQUIRED NON-SURGICAL ADDITIONAL SURGICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148814 URETEX SUPPORT PP TRANSOBTUR2 KIT X1 URETEX SUPPORT OTN SOFRADIM PRODUCTION SIJ00159

    Patients

    Seq Age Sex Outcome Treatment
    1 40/03/1 Other