BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX COMP 25X20CM W THR X1

    MDR report key: 1241539 · Received November 21, 2008

    Report

    Report Number
    9615742-2008-00034
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 21, 2008
    Report Date
    October 23, 2008
    Manufacturer
    TREVOUX - USS
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG #PCO2520F IS NOT SOLD IN THE USA AND IS NOT FDA APPROVED. HOWEVER, IT IS SIMILAR TO CATALOG #PC2520 WHICH IS SOLD IN THE USA AND IS FDA APPROVED.

    Description of Event or Problem · 1

    PROCEDURE: LAP IPOM. ACCORDING TO THE REPORTER: THE MESH WAS IMPLANTED IN 2008. THE PATIENT DEVELOPED AN ELEVATED TEMPERATURE AND THE MESH WAS EXPLANTED ON TWO DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARIETEX COMP 25X20CM W THR X1 SURGICAL MESH FTL TREVOUX - USS PIE00055

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other PROTACK 5 MM (SINGLE USE INSTRUMENT)