BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP POSTERIOR KIT X1

    MDR report key: 2971223 · Received February 6, 2013

    Report

    Report Number
    9615742-2013-00102
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    July 30, 2009
    Report Date
    August 27, 2015
    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). AS NO LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED. ALL PROCESS AND TEST CRITERIA ARE VERIFIED AS COMPLYING WITH THE FINISHED PRODUCT SPECIFICATIONS FOR ALL RELEASED LOTS. A REVIEW OF THE COMPLAINT DATA IDENTIFIED A TREND. THE IDENTIFIED TREND COMMENCED AFTER AN FDA SAFETY COMMUNICATION WAS ISSUED IN JULY 2011. THE INCREASED TREND INCLUDED COMPLAINTS RELATED TO LITIGATION FOR WHICH NO PREVIOUS COMPLAINTS HAD BEEN FILED.

    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. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED PAIN, INFECTION, UNSPECIFIED URINARY PROBLEMS, BLEEDING, AND DYSPAREUNIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51676 PARIETEX UGYTEX PP POSTERIOR KIT X1 MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN OTP SOFRADIM PRODUCTION UGYKP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other| R