BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFRADIM PRODUCT

    MDR report key: 2220107 · Received August 15, 2011

    Report

    Report Number
    9615742-2011-00066
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    December 22, 2004
    Report Date
    July 22, 2011
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PROCEDURE TYPE: HERNIA. ACCORDING TO THE REPORTER: ALLEGED PRODUCT INVOLVED "PRITEX DUAL MESH WITH PROLENE SUTURES". I HAVE BEEN HAVING SIGNIFICANT COMPLICATIONS AS A RESULT OF THIS HERNIA MESH. THE MESH IS APPLIED TO MY SMALL BOWEL. THIS HAS CREATED A GREAT DEAL OF PAIN. THIS INJURY WAS DISCOVERED ON (B)(6), 2011 THROUGH A CT SCAN. I HAVE BEEN CONSIDERING SURGERY TO HELP ALLEVIATE THE PAIN, AND PERHAPS REMOVE THE MESH. I HAVE BEEN TAKING OVER THE COUNTER MEDICINES FOR THE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFRADIM PRODUCT PARITEX MESH FTL SOFRADIM PRODUCTION

    Patients

    Seq Age Sex Outcome Treatment
    1