BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUPPORT PP KIT X1

    MDR report key: 3111772 · Received April 25, 2013

    Report

    Report Number
    9615742-2013-00338
    Event Type
    Injury
    Date Received
    April 25, 2013
    Date of Event
    October 21, 2002
    Report Date
    April 1, 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: STRESS URINARY INCONTINENCE. ACCORDING TO THE REPORTER: THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED: SUMMARY OF FACTS - WHAT WAS THE INDICATION FOR IMPLANTATION OF TRANSVAGINAL MESH IN THIS PATIENT? STRESS URINARY INCONTINENCE. WHAT WERE THE POSTOPERATIVE COMPLICATIONS THAT THIS PATIENT DEVELOPED FOLLOWING TRANSVAGINAL PLACEMENT OF SURGICAL MESH? ON (B)(6) 2002: UNDERWENT URETEX TRANSVAGINAL SLING PROCEDURE. COMPLICATIONS POST URETEX PLACEMENT: AS PER PFS, ¿OUTCOME ATTRIBUTED TO THE DEVICE INCLUDES: PAIN, INFECTION, URINARY PROBLEMS.¿ FOLLOWING MESH REVISION DID THE PATIENT PRESENT WITH SERIOUS COMPLICATIONS, WHICH REQUIRED ADDITIONAL SURGERIES? NO. AS PER THE AVAILABLE RECORDS, PATIENT DID NOT UNDERGO ANY MESH REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180101 URETEX SUPPORT PP KIT X1 URETEX SUPPORT OTN SOFRADIM PRODUCTION 22199SUP

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other