BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETELX TO2 URETHRAL SUPPORT SYSTEM

    MDR report key: 3172362 · Received April 18, 2013

    Report

    Report Number
    1018233-2013-01373
    Event Type
    Injury
    Date Received
    April 18, 2013
    Report Date
    March 20, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OTN
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADD'L INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR: 1018233-2013-01372 AND 01371.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168748 URETELX TO2 URETHRAL SUPPORT SYSTEM OTN SOFRADIM PRODUCTION NA SFL00435

    Patients

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