BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX COMP 20X15CM W THR X1

    MDR report key: 2133716 · Received June 9, 2011

    Report

    Report Number
    9615742-2011-00052
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 18, 2011
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: HERNIA. ACCORDING TO THE REPORTER: THE PATIENT COUGHED AND THE BOWEL BULGED THROUGH INCISION AND THERE WAS FOUND TO BE A TEAR IN MESH. THIS WAS REPLACED WITH ANOTHER PIECE OF MESH. PATIENT STATUS IS OK AND THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARIETEX COMP 20X15CM W THR X1 PARIETEX COMPOSITE MESH FTL SOFRADIM PRODUCTION PKK00531

    Patients

    Seq Age Sex Outcome Treatment
    1 Other