BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP 15X10CM X1

    MDR report key: 2900314 · Received December 21, 2012

    Report

    Report Number
    9615742-2012-00684
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    August 12, 2009
    Report Date
    May 9, 2018
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    PMA / PMN Number
    K033376
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADD'L DATA FROM IMPORTER REPORT: (B)(4) 2012; PELVITEX POLYPROPYLENE MESH; CATALOG #: 486015; (B)(6).

    Additional Manufacturer Narrative · 1

    MEDTRONIC COMPLAINT REPORT: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PROCEDURE: UROLOGICAL. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. ADD'L DATA FROM IMPORTER REPORT: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADD'L INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Description of Event or Problem · 1

    THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. THE INDICATION FOR IMPLANTATION OF TRANSVAGINAL MESH IN THIS PATIENT WAS CYSTOCELE, ENTEROCELE, AND APICAL URETERO VAGINAL PROLAPSE. COMPLICATIONS POST PLACEMENT: (B)(6) 2011 - CERVICAL STUMP PROLAPSE MESH REVISION SURGERY DETAILS: (B)(6) 2011 ¿ UNDERWENT LAPAROSCOPY, LYSIS OF ADHESIONS, CERVICAL STUMP SUSPENSION, CYSTOSCOPY WITH STUNT PLACEMENT, EXCISION OF VAGINAL MESH FOR CERVICAL STUMP PROLAPSE UNDER GENERAL ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARIETEX UGYTEX PP 15X10CM X1 PELVITEX MESH FTL SOFRADIM PRODUCTION NA PJC00350

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other| R