BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP 15X10CM X1

    MDR report key: 3040268 · Received March 26, 2013

    Report

    Report Number
    9615742-2013-00216
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    August 27, 2010
    Report Date
    February 27, 2013
    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).

    Additional Manufacturer Narrative · 1

    BRAND NAME: PELVITEX POLYPROPYLENE MESH. CATALOG: 486015. (B)(6).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. ADDITIONAL INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED,AS PER PFS, ¿OUTCOME ATTRIBUTED TO DEVICE ¿ PAIN, DYSPAREUNIA, URINARY PROBLEMS¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123711 PARIETEX UGYTEX PP 15X10CM X1 PELVITEX MESH FTL SOFRADIM PRODUCTION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other| R