BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP 15X10CM X1

    MDR report key: 3252303 · Received July 23, 2013

    Report

    Report Number
    9615742-2013-00920
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 24, 2009
    Report Date
    February 14, 2018
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    PMA / PMN Number
    K033376
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING NUMBER (B)(4). COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4) (IMPORTER).

    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: IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED INJURY, PAIN, SUFFERING, DISABILITY AND IMPAIRMENT. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. BARD PELVITEX POLYPROPYLENE MESH WAS REPORTED TO BE USED/IMPLANTED DURING THIS PROCEDURE.

    Description of Event or Problem · 1

    AS PER ADDITIONAL INFORMATION RECEIVED -PRE-OPERATIVE DIAGNOSIS: WAS SYMPTOMATIC PELVIC ORGAN PROLAPSE PROCEDURE (S) PERFORMED: A VAGINAL PARAVAGINAL REPAIR, CYSTOSCOPY, SUPRAPUBIC TUBE PLACEMENT, BILATERAL, SACROSPINOUS UTERINE SUSPENSION, POSTERIOR REPAIR AND USE OF GRAFT MATERIAL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343494 PARIETEX UGYTEX PP 15X10CM X1 PELVITEX MESH FTL SOFRADIM PRODUCTION PJB00393

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other