BEUDAMED
    FDA Adverse Event No answer provided Summary report: N

    PARIETEX UGYTEX PP 15X10CM X1

    MDR report key: 2718741 · Received August 23, 2012

    Report

    Report Number
    9615742-2012-00374
    Event Type
    No answer provided
    Date Received
    August 23, 2012
    Date of Event
    July 20, 2010
    Report Date
    July 26, 2012
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADD'L INFO FROM IMPORTER REPORT # (B)(4). (B)(6) 2012. BRAND NAME: PELVITEX POLYPROPYLENE MESH, PROCODE: FTL, CAT # 486015. (B)(6).

    Description of Event or Problem · 1

    PROCEDURE: UROLOGICAL/GYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT UNDERWENT A REPAIR PROCEDURE AND THE PT ALLEGEDLY EXPERIENCED PAIN AND INJURY. PT HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES. ADD'L INFO FROM IMPORTER REPORT # (B)(4): THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADD'L INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention| O ALIGN TO URETHRAL SUPPORT SYSTEM| ALIGN TO URETHRAL SUPPORT SYSTEM