BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX COMP 3D PY 15X10CM NO THRX1

    MDR report key: 1425365 · Received July 28, 2009

    Report

    Report Number
    9615742-2009-00073
    Event Type
    Injury
    Date Received
    July 28, 2009
    Report Date
    July 13, 2009
    Manufacturer
    TREVOUS - USS
    Product Code
    FTL
    PMA / PMN Number
    K040998
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: HERNIA REPAIR. ACCORDING TO THE REPORTER: AFTER A 2ND HERNIA OPERATION, PT IS LOOKING FOR A 2ND OPINION FOR A 3RD HERNIA OPERATION. CUSTOMER HAS STATED THAT SHE HAD TWO OPERATIONS REGARDING THE MESH. AFTER THE 2ND OPERATION, SHE LOST HER UTERUS AND OVARIES. THERE WAS NO INFECTION FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARIETEX COMP 3D PY 15X10CM NO THRX1 PARIETEX COMPOSITE MESH FTL TREVOUS - USS B23328

    Patients

    Seq Age Sex Outcome Treatment
    1 Other