BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP 15X10CM X1

    MDR report key: 2963200 · Received January 16, 2013

    Report

    Report Number
    9615742-2013-00009
    Event Type
    Injury
    Date Received
    January 16, 2013
    Date of Event
    September 24, 2004
    Report Date
    April 24, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADD'L INFO FROM THE IMPORTER REPORT: (B)(6); BRAND NAME: PELVITEX POLYPROPYLENE MESH; CAT # 4860153; (B)(6).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PROCEDURE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. ADD'L INFO FROM THE IMPORTER REPORT: ADD'L INFO HAS BEEN REQUESTED, BUT NOT REC'D. ASSOCIATED MDRS: 1018233-2013-00048 AND 1018233-2013-00050.

    Description of Event or Problem · 1

    THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. THE CONCOMITANT THERAPY WAS THE URETEX SUP URETHRAL SUPPORT SYSTEM PELVITEX POLYPROPYLENE MESH. THE REASON FOR MESH IMPLANTATION: VAGINAL VAULT PROLAPSE AND STRESS URINARY INCONTINENCE (SUI). THE PROCEDURE PERFORMED IS NOT AVAILABLE PER PATIENT RECORDS. THE COMPLICATIONS POST IMPLANTATION INCLUDE BODILY INJURIES, INCLUDING ANY EMOTIONAL OR PSYCHOLOGICAL INJURIES THAT PATIENT HAD RESULTED FROM THE IMPLANTATION OF THE MESH PRODUCT: STRESS URINARY INCONTINENCE (SUI), PELVIC ORGAN PROLAPSE, INFECTIONS, CHRONIC PAIN. DEPRESSION AND ANXIETY. THE PATIENT FELT THAT THE MESH HAS POPPED. SHE ALSO HAD FECAL INCONTINENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25269 PARIETEX UGYTEX PP 15X10CM X1 PELVITEX MESH FTL SOFRADIM PRODUCTION NA P24022G3

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other| R POLYPROPYLENE MESH| URETEX SUP URETHRAL SUPPORT SYS PELVITEX