BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUPPORT PP TRANSOBTUR2 KIT X1

    MDR report key: 2990036 · Received February 19, 2013

    Report

    Report Number
    9615742-2013-00092
    Event Type
    Injury
    Date Received
    February 19, 2013
    Date of Event
    June 13, 2006
    Report Date
    May 11, 2018
    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
    ATTORNEY
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADD'L INFO (B)(4): DEVICE INFO: URETEX TO2 URETHRAL SUPPORT SYSTEM, CAT #485054. (B)(6).

    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. (B)(4): PER ADD'L INFO RECEIVED, THE PT HAS EXPERIENCED RECURRENT VAGINAL PROLAPSE REQUIRING TWO ADD'L SURGERIES. ASSOCIATED MDR: 1018233-00412, 00410 AND 00411.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72494 URETEX SUPPORT PP TRANSOBTUR2 KIT X1 URETEX SUPPORT FTL SOFRADIM PRODUCTION SGA00194

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Other AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM| AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM