BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUP URETHRAL SUPPORT SYSTEM

    MDR report key: 3192852 · Received May 3, 2013

    Report

    Report Number
    1018233-2013-01722
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    April 5, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OTN
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PER ADD'L INFO RECEIVED, THE PT HAS EXPERIENCED SURGICAL COMPLICATIONS, STRESS URINARY INCONTINENCE, ANTERIOR REPAIR, PARTIAL VAGINECTOMY, AND PLACEMENT OF SUPRAPUBIC CYSTOTOMY TUBE. PER ADD'L INFO RECEIVED, THE PT HAS EXPERIENCED URINARY RETENTION REQUIRING INTERMITTENT CATHETERIZATION AND URETHROLYSIS; SEVERE PAIN IN THE VAGINA AND BILATERAL GROINS; AND PAIN WITH INTERCOURSE. ASSOCIATED MDR: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195751 URETEX SUP URETHRAL SUPPORT SYSTEM OTN SOFRADIM PRODUCTION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention THE ADVANTAGE TRANSVAGINAL MID-URETHRAL SLING SYST| THE ADVANTAGE FIT SYSTEM| AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM