BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUPPORT PP TRANSOBTUR2 KIT X1

    MDR report key: 2901236 · Received November 16, 2012

    Report

    Report Number
    9615742-2012-00576
    Event Type
    Injury
    Date Received
    November 16, 2012
    Date of Event
    December 15, 2006
    Report Date
    April 25, 2018
    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). ADDITIONAL INFO: (B)(6).

    Description of Event or Problem · 1

    PROCEDURE: UROLOGICAL/GYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT UNDERWENT A REPAIR PROCEDURE AND THE PT ALLEGEDLY EXPERIENCED PAIN AND INJURY. PT HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES. IT WAS REPORTED BY THE PT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PT HAS EXPERIENCED PAIN, SUPPERING, DISABILITY AND IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URETEX SUPPORT PP TRANSOBTUR2 KIT X1 URETEX SUPPORT OTN SOFRADIM PRODUCTION N SGI00088

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| O