BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUPPORT PP TRANSOBTUR2 KIT X1

    MDR report key: 2901157 · Received October 31, 2012

    Report

    Report Number
    9615742-2012-00560
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    April 25, 2018
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    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). (AVAULTA ANTERIOR). NOTE: THIS REPORT CORRESPONDS WITH BARD'S REPORT #409708 FOR A "URETEX." ADDITIONAL INFORMATION FROM THE IMPORTER REPORT: (B)(6) 2012, URETEX TO2 URETHRAL SUPPORT SYSTEM, CATALOG # 485054, (B)(6). ATTORNEY.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PROCEDURE: UROLOGICAL/GYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PATIENT UNDERWENT A REPAIR PROCEDURE AND THE PATIENT ALLEGEDLY EXPERIENCED PAIN AND INJURY. PATIENT HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES. THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A REPAIR PROCEDURE AND THE PATIENT ALLEGEDLY EXPERIENCED PAIN AND INJURY. REASON FOR MESH IMPLANTATION: STRESS URINARY INCONTINENCE, CYSTOCELE, BILATERAL OVARIAN CYST PROCEDURE (S) PERFORMED: AVAULTA ANTERIOR MESH CYSTOSCOPE AND URETEX TRANSOBTURATOR TAPE (TOT) AND LAPAROSCOPY BILATERAL SALPING OOP HORECTOMY. FINDINGS: 2+ CYSTOCELE, LOSS OF URINE, BILATERAL CYSTS CONCOMITANT THERAPY: AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM COMPLICATIONS POST PLACEMENT: ¿OUTCOME ATTRIBUTED TO DEVICE INCLUDES IRRITABLE BOWEL SYNDROME, DYSPAREUNIA, HYPERTENSION, YEAST INFECTIONS, COLORED DISCHARGE, MESH ATTACHED TO OVARY SHARP BURNING PAIN.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URETEX SUPPORT PP TRANSOBTUR2 KIT X1 URETEX SUPPORT FTL SOFRADIM PRODUCTION NA SGE00121

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other| R AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM