BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX STD 3D PY 15X15CM X1

    MDR report key: 2032589 · Received March 22, 2011

    Report

    Report Number
    9615742-2011-00025
    Event Type
    Injury
    Date Received
    March 22, 2011
    Date of Event
    August 1, 2009
    Report Date
    February 23, 2011
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    PMA / PMN Number
    K982532
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE PT HAS ALLERGIES WITH THE DEVICE THAT WAS PUT IN PLACE IN (B)(6) 2009 AND THE DEVICE HAD TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARIETEX STD 3D PY 15X15CM X1 PARIETEX MESH FTL SOFRADIM PRODUCTION SJB00169

    Patients

    Seq Age Sex Outcome Treatment
    1 Other