BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP ANTERIOR KIT X1

    MDR report key: 2900327 · Received October 31, 2012

    Report

    Report Number
    9615742-2012-00519
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    November 15, 2006
    Report Date
    October 4, 2012
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    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: UROLOGICAL/GYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT UNDERWENT A REPAIR PROCEDURE AND THE PT ALLEGEDLY EXPERIENCED PAIN AND INJURY. PT HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES. ADD'L DATA FROM IMPORTER REPORT: IT WAS REPORTED BY THE PT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PT HAS EXPERIENCED PAIN, DISABILITY, AND IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARIETEX UGYTEX PP ANTERIOR KIT X1 AVAULTA ANTERIOR SYSTEM FTL SOFRADIM PRODUCTION NA ZGD00675

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM