BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-QUR MESH DEVICE

    MDR report key: 2484926 · Received January 6, 2012

    Report

    Report Number
    1219977-2011-00012
    Event Type
    Malfunction
    Date Received
    January 6, 2012
    Date of Event
    January 7, 2011
    Report Date
    January 5, 2012
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER MAUDE EVENT REPORT ((B)(4)) SUBMITTED BY PT. THE PT STATED INITIALLY SHE THOUGHT SHE WAS HAVING ¿REDO¿ OF A RIGHT INGUINAL HERNIA REPAIR WHICH WAS SUCCESSFULLY FIXED IN 2008. SHE THEN BEGAN TO EXPERIENCE INCREASING PAIN IN HER RIGHT GROIN, RADIATING TO HER RIGHT LABIA BUT ALSO EXPERIENCED A SHOOTING PAIN DOWN HER FRONT RIGHT THIGH. SHE WENT TO THE OPERATING ROOM IN 2011 AND SHE WAS FOUND TO HAVE AN OBTURATOR HERNIA, WITH A PERITONEAL SAC CONTAINING FLUID IN HER RIGHT THIGH. THE SURGEON USED C-QUR MESH, COATED WITH OMEGA-3 FISH OIL TO REPAIR THE HERNIA. SHE STATED SHE NEVER RECOVERED FROM THE SURGERY AND HAS EXPERIENCED INCREASING BURNING AND SHOOTING PAIN, FIRST ON THE RIGHT SIDE AND THEN ON THE LEFT SIDE. SHE WAS TAKEN BACK TO OPERATING ROOM WHERE THE SURGEON REMOVED ALL OF THE ATRIUM C-QUR MESH, FEELING THAT SHE WAS HAVING A REACTION TO THE MESH. SHE ALSO STATED THAT THE MESH WAS FLOATING FREELY IN HER ABD/PELVIC CAVITY AND HAD BECOME ENMESHED IN HER APPENDIX NECESSITATING AN APPENDECTOMY. HER LAST SURGERY WAS IN (B)(6) 2011. SHE DEVELOPED ADHESIONS IN THE ABD/PELVIC AND INGUINAL AREA, WITH ONLY SUTURES LEFT TO REPAIR HER HERNIAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-QUR MESH DEVICE FTL ATRIUM MEDICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization