BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP POSTERIOR KIT X1

    MDR report key: 2234043 · Received August 29, 2011

    Report

    Report Number
    9615742-2011-00074
    Event Type
    Injury
    Date Received
    August 29, 2011
    Date of Event
    May 24, 2007
    Report Date
    July 27, 2011
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    PMA / PMN Number
    K051503
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MDR REF #: 9615742-2011-00078 (AVAULTA ANTERIOR BIOSYNTH. SYSTEM). NOTE: THIS REPORT CORRESPONDS WITH BARD'S REPORT #334701 FOR "AVAULTA POSTERIOR SYSTEM".

    Additional Manufacturer Narrative · 1

    (B)(4). SUPPLEMENTAL MDR# 01 SENT TO FDA ON 02/24/2015.

    Description of Event or Problem · 1

    REVIEWER'S COMMENTS: INTERIM RECORDS FROM (B)(6) 2007 TO (B)(6) 2012 ARE NOT AVAILABLE FOR REVIEW TO KNOW THE HEALTH STATUS OF THE PATIENT MESH REVISION WITH ADDITIONAL IMPLANT (TUTOPLAST RECTUS FASCIA) SURGERY: ON (B)(6) 2012 PATIENT UNDERWENT REMOVAL OF ANTERIOR VAGINAL WALL MESH (ANTERIOR AVAULTA BY BARD), REMOVAL OF TRANSOBTURATOR SLING VAGINAL PORTION, IRRIGATION AND WASHOUT PROTOCOL, ANTERIOR REPAIR WITH TUTOPLAST, FASCIAL REINFORCEMENT (6 X 8 CM PIECE OF CADAVERIC FASCIA) WITH SACROSPINOUS LIGAMENT FIXATION, PUBOVAGINAL SLING UTILIZING AUTOLOGOUS RECTUS FASCIA, CYSTOSCOPY PLACEMENT OF SUPRAPUBIC CYSTOTOMY TUBE.

    Description of Event or Problem · 1

    PROCEDURE: UROLOGICAL/GYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT UNDERWENT A POSTERIOR AND ANTERIOR PROCEDURES FOR TREATMENT OF PELVIC ORGAN PROLAPSE. THE PT ALLEGEDLY EXPERIENCED PAIN AND INJURY. PT HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARIETEX UGYTEX PP POSTERIOR KIT X1 AVAULTA POSTERIOR BIOSYNTH SYSTEM FTL SOFRADIM PRODUCTION ZGJ00492

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other| R