BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP ANTERIOR KIT X1

    MDR report key: 3220946 · Received July 3, 2013

    Report

    Report Number
    9615742-2013-00708
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    June 22, 2007
    Report Date
    October 28, 2024
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OTP
    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).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303493 PARIETEX UGYTEX PP ANTERIOR KIT X1 AVAULTA ANTERIOR SYSTEM OTP SOFRADIM PRODUCTION ZGI00340

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Other LOT #ZGJ00163, EXP: 09/30/2011, MFR: 09/2006.| PARIETEX UGYTEX PP POSTERIOR KIT: UGYKP, LOT #ZGJ00163, EXP: 09/30/2011, MFR: 10/2006| LOT #ZGJ00163, EXP: 09/30/2011, MFR: 09/2006| PARIETEX UGYTEX PP POSTERIOR KIT: UGYKP