BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUPPORT PP TRANSOBTUR2 KIT X1

    MDR report key: 3001029 · Received February 28, 2013

    Report

    Report Number
    9615742-2013-00130
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    February 16, 2003
    Report Date
    February 27, 2018
    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
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BRAND NAME: URETEX URETHRAL SUPPORT SYSTEM, CATALOG#: 485054, (B)(6).

    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 TYPE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR: 1018233-2013-00515.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, REASON FOR MESH IMPLANTATION: CYSTOCELE, RECTOCELE, VAULT PROLAPSE PROCEDURE (S) PERFORMED: ANTERIOR COLPORRHAPHY WITH GRAFT, POSTERIOR COLPORRHAPHY WITH GRAFT, SACROCOLPOPEXY, SUBURETHRAL SLING (TRANSOBTURATOR). COMPLICATIONS POST IMPLANT: IN 2011 - PATIENT EXPERIENCED DYSPAREUNIA, SUPRAPUBIC ABDOMINAL PAIN, CRAMPING FEELING IN SUPRAPUBIC (SP) AREA, SMALL AMOUNT OF DYSURIA PELVIC SOME MILD BLADDER COMPLAINTS. IN VAGINA-GRADE I CYSTOCELE, GRADE I RECTOCELE - URINARY TRACT INFECTION (UTI), POSTMENOPAUSAL ATROPHIC VAGINITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86594 URETEX SUPPORT PP TRANSOBTUR2 KIT X1 URETEX SUPPORT OTN SOFRADIM PRODUCTION NA SFI00281

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other| R PELVITEX POLYPROPYLENE MESH