BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARIETENE PROGRIP RT PPL/PLA 12X8CM

    MDR report key: 1243094 · Received November 21, 2008

    Report

    Report Number
    9615742-2008-00033
    Event Type
    Malfunction
    Date Received
    November 21, 2008
    Date of Event
    October 2, 2008
    Report Date
    November 14, 2008
    Manufacturer
    TREVOUX - USS
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PARIETENE PROGRIP (POLYPROPYLENE BASED) IS NOT SOLD IN THE US AND HAS NO 510K. PARIETEX PROGRIP (POLYESTER BASED) IS SOLD IN THE US.

    Description of Event or Problem · 1

    PROCEDURE: LICHTENSTEIN. ACCORDING TO THE REPORTER: THE FLAP BROKE AWAY WHEN OPENING THE PROGRIP THE FIRST TIME. A NEW PROGRIP WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARIETENE PROGRIP RT PPL/PLA 12X8CM SURGICAL MESH FTL TREVOUX - USS SIG00042

    Patients

    Seq Age Sex Outcome Treatment
    1