BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUPPORT PP KIT X1

    MDR report key: 2930528 · Received January 16, 2013

    Report

    Report Number
    9615742-2013-00026
    Event Type
    Injury
    Date Received
    January 16, 2013
    Date of Event
    May 16, 2005
    Report Date
    June 28, 2018
    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

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFO FROM THE IMPORTER REPORT: DATE OF REPORT: (B)(4) 2012; PRODUCT NAME: URETEX SUP URETHRAL SUPPORT SYSTEM; CATALOG#: 1485013; (B)(6).

    Description of Event or Problem · 1

    PROCEDURE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT'S REPORTEDLY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. PELVISOFT ACELLULAR COLLAGEN BIOMESH WAS REPORTED TO BE USED/IMPLANTED DURING THIS PROCEDURE. ADDITIONAL INFO FROM THE IMPORTER REPORT: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDRS: 1018233-2013-00090, 1018233-2012-00091.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24588 URETEX SUPPORT PP KIT X1 URETEX SUPPORT FTL SOFRADIM PRODUCTION NA SFBO0081

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other| R PELVISOFT ACELLULAR COLLAGEN BIOMESH| PELVISOFT ACELLULAR COLLAGEN BIOMESH