BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUPPORT PP TRANSOBTUR2 KIT X1

    MDR report key: 3001085 · Received February 28, 2013

    Report

    Report Number
    9615742-2013-00137
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    December 28, 2005
    Report Date
    April 3, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BRAND NAME: URETEX TO2 URETHRAL SUPPORT SYSTEM, CATALOG # 4850543. (B)(6).

    Additional Manufacturer Narrative · 1

    MEDTRONIC COMPLAINT REPORT: (B)(4). ADDITIONAL INFORMATION: (B)(4): RECURRENCE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, REASON FOR MESH IMPLANTATION: STRESS URINARY INCONTINENCE PROCEDURE (S) PERFORMED: TENSION FREE VAGINAL TAPE THROUGH THE OBTURATOR CANAL COMPLICATIONS POST IMPLANT- PAIN, URINARY PROBLEMS AND RECURRENCE, URINARY PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86886 URETEX SUPPORT PP TRANSOBTUR2 KIT X1 URETEX SUPPORT OTN SOFRADIM PRODUCTION NA SFF00682

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other| R