BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUPPORT PP KIT X1

    MDR report key: 2963155 · Received January 31, 2013

    Report

    Report Number
    9615742-2013-00048
    Event Type
    Injury
    Date Received
    January 31, 2013
    Date of Event
    February 23, 2004
    Report Date
    October 5, 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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE; UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. ADDITIONAL INFO FROM IMPORTER REPORT: ASSOCIATED MDR: 1018233-2013-00223.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42696 URETEX SUPPORT PP KIT X1 URETEX SUPPORT FTL SOFRADIM PRODUCTION NA C232132UP

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention| O PELVICOL ACELLULAR COLLAGEN MATRIX| PELVICOL ACELLULAR COLLAGEN MATRIX