BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP ANTERIOR KIT X1

    MDR report key: 3131369 · Received May 10, 2013

    Report

    Report Number
    9615742-2013-00400
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    November 9, 2006
    Report Date
    April 12, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OTP
    PMA / PMN Number
    K051503
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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. GYNECARE VT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209417 PARIETEX UGYTEX PP ANTERIOR KIT X1 AVAULTA ANTERIOR SYSTEM OTP SOFRADIM PRODUCTION ZGD00283

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other PARIETEX UGYTEX PP POSTERIOR KIT X1, UGYKP,| LOT# ZGH0014, EXP: 08/31/2011, MFR: 08/2006