BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP POSTERIOR KIT X1

    MDR report key: 3131343 · Received May 17, 2013

    Report

    Report Number
    9615742-2013-00427
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    August 10, 2006
    Report Date
    May 8, 2018
    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
    Health Professional
    N

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220058 PARIETEX UGYTEX PP POSTERIOR KIT X1 AVAULTA POSTERIOR SYSTEM OTP SOFRADIM PRODUCTION ZGE00582

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Other UGYKA PARIETEX UGYTEX PP ANTERIOR KIT X1: ZGC00156, EXP: 03/31/2011, MFR: 03/2006| PARIETEX UGYTEX PP ANTERIOR KIT X1: (B)(4)| EXP: 03/31/2011, MFR: 03/2006| UGYKA