BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP POSTERIOR KIT X1

    MDR report key: 3093884 · Received April 24, 2013

    Report

    Report Number
    9615742-2013-00315
    Event Type
    Injury
    Date Received
    April 24, 2013
    Date of Event
    February 20, 2007
    Report Date
    March 27, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OTP
    PMA / PMN Number
    K051503
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: STRESS URINARY INCONTINENCE. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PELVISOFT WAS REPORTED TO BE USED/IMPLANTED DURING THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176601 PARIETEX UGYTEX PP POSTERIOR KIT X1 AVAULTA POSTERIOR SYSTEM OTP SOFRADIM PRODUCTION ZGJ00012

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other CAT # UGYKA, LOT # ZGG00688| PARIETEX UGYTEX PP ANTERIOR KIT X1,