BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX TO KIT

    MDR report key: 3203739 · Received March 27, 2013

    Report

    Report Number
    1018233-2013-00986
    Event Type
    Injury
    Date Received
    March 27, 2013
    Report Date
    February 26, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OTN
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PT HAS EXPERIENCED PAIN, INJURY, DISABILITY AND IMPAIRMENT. ASSOCIATED MDRS: 1018233-2013-00984 AND 1018233-2013-00985.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127422 URETEX TO KIT OTN SOFRADIM PRODUCTION NA 24198TO

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PELVITEX POLYPROPYLENE MESH| PELVITEX POLYPROPYLENE MESH