BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUPPORT PP TRANSOBTUR KIT X1

    MDR report key: 2793825 · Received September 28, 2012

    Report

    Report Number
    9615742-2012-00457
    Event Type
    Injury
    Date Received
    September 28, 2012
    Report Date
    August 30, 2012
    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). ADDITIONAL INFORMATION: DATE OF REPORT: (B)(4) 2012, DEVICE INFO: URETEX URETHRAL SUPPORT SYSTEM, DEVICE MFR: SOFRADIM PRODUCTION, (B)(4), CATALOG# 485054, (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 TRANSOBTUR KIT X1 URETEX SUPPORT FTL SOFRADIM PRODUCTION NA SGJ00260

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other| R