BEUDAMED
    FDA Adverse Event Other Summary report: N

    URETEX TO2 URETHRAL SUPPORT SYSTEM

    MDR report key: 5341434 · Received January 4, 2016

    Report

    Report Number
    1018233-2012-02049
    Event Type
    Other
    Date Received
    January 4, 2016
    Report Date
    December 8, 2015
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 0

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED FREQUENCY, URGENCY, LEAKAGE, INCOMPLETE EMPTYING, DYSURIA, VAGINAL BURNING, ATROPHIC VAGINA, RECURRENT URINARY TRACT INFECTION (UTI), CYSTITIS (INFLAMMATION), CHRONIC KIDNEY DISEASE II-IV, OVERACTIVE BLADDER, BACK PAIN/FLANK PAIN, ESCHERICHIA COLI IN URINE (BACTERIAL INFECTION), UNSTABLE COUMADIN LEVELS, CHILLS, LOSS OF/POOR APPETITE, FATIGUE, JOINT PAIN, REDUCED MUSCLE STRENGTH/MUSCLE WEAKNESS (WEAKNESS), NUMBNESS, UNSTEADY GAIT/LIMPING/STIFFNESS, HYPERGLYCEMIA, DISTRESS, DRY MOUTH, LIGHTHEADEDNESS, PALPITATIONS, ABNORMAL BRUISING (BRUISES), REDUCED MUSCLE TONE, THRUSH, BILATERAL SHOULDER PAIN, DEPRESSION, SMALL/LARGE BLOOD IN URINE (HEMATURIA), LEUKOCYTES/PROTEIN/GLUCOSE IN URINE, FRUSTRATION WITH VOIDING HABITS, WEIGHT GAIN (WEIGHT FLUCTUATIONS), DIFFICULTY LYING/SITTING UP, FUNNY TASTE ON TONGUE, ANXIETY, NERVOUSNESS AND REQUIRED ADDITIONAL NONSURGICAL INTERVENTIONS.

    Description of Event or Problem · 0

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED CHRONIC CONSTIPATION, DIABETES, HYPERTENSION, RECURRENT RECTOCELE, RECURRENT UTERINE PROLAPSE, RECURRENT VAGINAL VAULT PROLAPSE, SEVERE ABDOMINAL AND VAGINAL PAIN, PERITONITIS/SEPSIS, RECURRENT VAGINAL PAIN, RECURRENT URINARY INCONTINENCE, URINARY RETENTION, NOCTURIA, RECURRENT INFECTIONS, AND MUSCLE SPASMS/CRAMPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2737 URETEX TO2 URETHRAL SUPPORT SYSTEM Mesh, surgical, polymeric FTL SOFRADIM PRODUCTION NA SGJ00155

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM: POSTERIOR