BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUPPORT PP HALO NEEDLE KIT X1

    MDR report key: 2316777 · Received October 28, 2011

    Report

    Report Number
    9615742-2011-00094
    Event Type
    Injury
    Date Received
    October 28, 2011
    Report Date
    September 28, 2011
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    PMA / PMN Number
    K041176
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SEE 915742-2011-00093 (AVAULTA ANTERIOR SYSTEM). NOTE: THIS REPORT CORRESPONDS WITH BARD'S REPORT (B)(4) FOR A URETEX."

    Description of Event or Problem · 1

    PROCEDURE: UROLOGICAL/GYNECOLOGICAL. ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT A PROCEDURE FOR TREATMENT OF PELVIC ORGAN PROLAPSE AND STRESS URINARY INCONTINENCE. ALLEGEDLY, THE PATIENT EXPERIENCED PAIN, INJURY AND HAS UNDERGONE CORRECTIVE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URETEX SUPPORT PP HALO NEEDLE KIT X1 URETEX TO3 FTL SOFRADIM PRODUCTION SFI00534

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other| R