BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUPPORT PP KIT X1

    MDR report key: 3111729 · Received April 16, 2013

    Report

    Report Number
    9615742-2013-00328
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    December 20, 2005
    Report Date
    March 18, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT ALLEGED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164084 URETEX SUPPORT PP KIT X1 URETEX SUPPORT FTL SOFRADIM PRODUCTION SFE00513

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other