BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUPPORT PP TRANSOBTUR2 KIT X1

    MDR report key: 3231715 · Received July 12, 2013

    Report

    Report Number
    9615742-2013-00763
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    August 22, 2005
    Report Date
    June 17, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OTN
    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

    TRACKING NUMBER (B)(4). COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4) (IMPORTER).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: AGE (B)(6) - THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323474 URETEX SUPPORT PP TRANSOBTUR2 KIT X1 URETEX SUPPORT OTN SOFRADIM PRODUCTION SFB00337

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other 482047, LOT# 04B15-1| PELVICOL ACELLULAR COLLAGEN MATRIX 4X7CM:| 482047, LOT# 04B15-1| PELVICOL ACELLULAR COLLAGEN MATRIX 4X7CM: