BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX TO2 URETHRAL SUPPORT SYSTEM

    MDR report key: 3213439 · Received May 6, 2013

    Report

    Report Number
    1018233-2013-01762
    Event Type
    Injury
    Date Received
    May 6, 2013
    Report Date
    November 10, 2017
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    OTN
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN, DISABILITY AND IMPAIRMENT. ASSOCIATED MDR: 1018233-2013-01759 AND 1018233-2013-01761.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197908 URETEX TO2 URETHRAL SUPPORT SYSTEM URETEX TO2 URETHRAL SUPPORT W/HOOK NEEDLE OTN C.R. BARD, INC. (COVINGTON) -1018233 NA SGC00619

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM| AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM| AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM| AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM