BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUPPORT PP TRANSOBTUR2 KIT X1

    MDR report key: 3082900 · Received April 22, 2013

    Report

    Report Number
    9615742-2013-00310
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    May 1, 2007
    Report Date
    March 26, 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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN, INJURY, DISABILITY AND IMPAIRMENT. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172144 URETEX SUPPORT PP TRANSOBTUR2 KIT X1 URETEX SUPPORT OTN SOFRADIM PRODUCTION SGJ00384

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Other