BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARIETEX COMP 25X20 CM W THR X1

    MDR report key: 1901079 · Received November 10, 2010

    Report

    Report Number
    9615742-2010-00050
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    September 24, 2010
    Report Date
    October 12, 2010
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP HERNIA REPAIR. ACCORDING TO THE REPORTER: THE MESH TORE BETWEEN TWO TACKS. THE SURGEON HAD TO THEN TIE A PURSE STRING STITCH AROUND THE TEAR. THERE WAS NO ADDITIONAL BLOOD LOSS OF 250 CCS OR MORE OR TISSUE DAMAGE DUE TO THE REPORTED. NOTHING FELL INTO THE PATIENT'S CAVITY. A PURSE STRING SUTURE WAS TIED AROUND THE TORN MESH TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARIETEX COMP 25X20 CM W THR X1 PARIETEX COMPOSITE MESH FTL SOFRADIM PRODUCTION PKF00373

    Patients

    Seq Age Sex Outcome Treatment
    1