BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX TO2 URETHRAL SUPPORT SYSTEM

    MDR report key: 3213481 · Received May 8, 2013

    Report

    Report Number
    1018233-2013-01805
    Event Type
    Injury
    Date Received
    May 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OTN
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, 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, SUFFERING, DISABILITY AND IMPAIRMENT. ASSOCIATED MDR: 1018233-2013-01804 AND 1018233-2013-01811.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202486 URETEX TO2 URETHRAL SUPPORT SYSTEM OTN SOFRADIM PRODUCTION NA SGA00194

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM| AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM