BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP POSTERIOR KIT X1

    MDR report key: 3202348 · Received June 21, 2013

    Report

    Report Number
    9615742-2013-00541
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 13, 2007
    Report Date
    May 13, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    PMA / PMN Number
    K05150
    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 (B)(4) (IMPORTER). BARD'S TRACKING NUMBER: (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: PELVIC ORGAN PROLAPSE. ACCORDING TO THE REPORTER: THE PATIENT ALLEGED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283360 PARIETEX UGYTEX PP POSTERIOR KIT X1 AVAULTA POSTERIOR SYSTEM FTL SOFRADIM PRODUCTION ZGI00501

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other LOT NUMBER: ZGF00605, EXP: 07/31/2011| MFR: 07/01/2006| UGYKA, PARIETEX UGYTEX PP ANTERIOR KIT X1| MFR: 07/01/2006| LOT NUMBER: ZGF00605, EXP: 07/31/2011| UGYKA, PARIETEX UGYTEX PP ANTERIOR KIT X1