BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP POSTERIOR KIT X1

    MDR report key: 4212872 · Received October 30, 2014

    Report

    Report Number
    9615742-2014-00327
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    July 13, 2007
    Report Date
    October 10, 2014
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OTP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED INJURY, PAIN, DISABILITY AND IMPAIRMENT. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695388 PARIETEX UGYTEX PP POSTERIOR KIT X1 PARIETEX UGYTEX PP OTP SOFRADIM PRODUCTION UGYKP ZGK00347

    Patients

    Seq Age Sex Outcome Treatment
    1 Other