BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUPPORT PP KIT X1

    MDR report key: 3014226 · Received March 5, 2013

    Report

    Report Number
    9615742-2013-00166
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    April 19, 2006
    Report Date
    February 8, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OTN
    PMA / PMN Number
    K012949
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BRAND NAME: URETEX SUP URETHRAL SUPPORT SYSTEM. CATALOG #: 485013. (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PROCEDURE TYPE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. AN UNK ALIGN RETROPUBIC SUPPORT SYSTEM WAS REPORTED TO BE USED/IMPLANTED DURING THIS PROCEDURE. ADDITIONAL INFORMATION FROM THE IMPORTER REPORT: ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR: 1018233-2013-00654.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED RECURRENT GENUINE STRESS URINARY INCONTINENCE, SYMPTOMATIC CYSTOCELE (PROLAPSE), FOREIGN BODY IN PATIENT, EROSION, BLOOD LOSS, APICAL PROLAPSE, GRAFT EXPOSURE, GENITOURINARY TRACT, EXTRUSION, OBSTRUCTIVE TYPE VOIDING SYMPTOMS, INCOMPLETE BLADDER EMPTYING, DEPRESSION, ANXIETY, FOREIGN BODY SENSATION, URINARY URGENCY, LOW GRADE FEVER, URGE INCONTINENCE, URINARY RETENTION, PUSHING/STRAINING TO URINATE, URINARY LEAKAGE, COAG NEGATIVE STAPHYLOCOCCUS (INFECTION), LOW BACK PAIN, NON-SURGICAL AND ADDITIONAL SURGICAL INTERVENTIONS. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT REQUIRED NON-SURGICAL AND ADDITIONAL SURGICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95108 URETEX SUPPORT PP KIT X1 MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN SOFRADIM PRODUCTION NA SGA00402

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R