BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP POSTERIOR KIT XL

    MDR report key: 3411009 · Received October 3, 2013

    Report

    Report Number
    9615742-2013-01864
    Event Type
    Injury
    Date Received
    October 3, 2013
    Date of Event
    November 29, 2006
    Report Date
    June 24, 2018
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OTO
    PMA / PMN Number
    K051503
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF C.R. BARD, INC.

    Description of Event or Problem · 1

    PROCEDURE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT ALLEGED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501146 PARIETEX UGYTEX PP POSTERIOR KIT XL AVAULTA POSTERIOR SYSTEM OTO SOFRADIM PRODUCTION ZGT00452

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Other AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM| URETEX SUP URETHRAL SUPPORT SYSTEM