BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUPPORT PP KIT X1

    MDR report key: 3131060 · Received May 21, 2013

    Report

    Report Number
    9615742-2013-00461
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    December 12, 2009
    Report Date
    April 25, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OTN
    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 PATIENT'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
    225634 URETEX SUPPORT PP KIT X1 URETEX SUPPORT OTN SOFRADIM PRODUCTION

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Other 12 FRENCH SUPRAPUBIC CATHETER| URETEX SUPPORT PP KIT X1: LOT # UNK| URETEXSUP| URETEX SUPPORT PP KIT X1: LOT # UNK| URETEXSUP