BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP 15X10CM X1

    MDR report key: 2895251 · Received December 11, 2012

    Report

    Report Number
    9615742-2012-00655
    Event Type
    Injury
    Date Received
    December 11, 2012
    Date of Event
    October 20, 2006
    Report Date
    November 15, 2012
    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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFO FROM IMPORTER REPORT: (B)(4) 2012. PELVITEX POLYPROPYLENE MESH. (B)(4). (B)(6).

    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. ADDITIONAL INFO FROM IMPORTER REPORT: ADDITIONAL INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDRS# 1018233-2012-02009 AND 1018233-2012-02010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARIETEX UGYTEX PP 15X10CM X1 PELVITEX MESH FTL SOFRADIM PRODUCTION NA PGH00119

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention| O URETEX SUP URETHRAL SUPPORT SYSTEM| URETEX TO2 URETHRAL SUPPORT SYSTEM| URETEXSUP URETEX SUPPORT PP KIT X1, LOT NUMBER NOT AVAILABLE| URETEXT02 URETEX SUPPORT PP TRAI4SOBTUR2 KIT X1, LOT NUMBER SGH00084 | URETEXTO2 URETEX KIT, URETEXSUP URETEX KIT| URETEX TO2 URETHRAL SUPPORT SYSTEM| URETEX SUP URETHRAL SUPPORT SYSTEM