BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URETEX SUPPORT PP KIT X1

    MDR report key: 3220975 · Received July 3, 2013

    Report

    Report Number
    9615742-2013-00727
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    December 30, 2005
    Report Date
    February 11, 2016
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OTN
    PMA / PMN Number
    K012949
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PATIENT ALLEGED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304299 URETEX SUPPORT PP KIT X1 URETEX SUPPORT OTN SOFRADIM PRODUCTION SFI00185

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Other