BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUPPORT PP KIT X1

    MDR report key: 2903152 · Received October 8, 2012

    Report

    Report Number
    9615742-2012-00499
    Event Type
    Injury
    Date Received
    October 8, 2012
    Date of Event
    September 5, 2006
    Report Date
    September 7, 2012
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    PMA / PMN Number
    K012949
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    SD REFERENCE #: (B)(4). DATE OF INITIAL REPORT SENT: (B)(4) 2012. NOTE: THIS REPORT CORRESPONDS WITH BARD'S REPORT #(B)(4) FOR A "URETEX". ADDITIONAL INFORMATION FROM THE IMPORTER REPORT: DATE OF REPORT: (B)(4) 2012, NAME OF PRODUCT: URETEX SUP URETHRAL SUPPORT SYSTEM, CATALOG #485013, (B)(6).

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URETEX SUPPORT PP KIT X1 URETEX SUPPORT FTL SOFRADIM PRODUCTION NA SGF00348

    Patients

    Seq Age Sex Outcome Treatment
    1 Female