BEUDAMED
    FDA Adverse Event Death Summary report: N

    GUT SURGICAL SUTURE

    MDR report key: 499131 · Received December 4, 2003

    Report

    Report Number
    2210968-2003-00474
    Event Type
    Death
    Date Received
    December 4, 2003
    Date of Event
    August 27, 2001
    Report Date
    November 19, 2003
    Manufacturer
    ETHICON, INC., SAN LORENZO
    Product Code
    GAL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD SURGERY TO REPAIR A "RUPTURED" AORTIC ANEURYSM IN 1995. ABSORBABLE AND NON-ABSORBABLE SUTURES WERE USED. THREE DAYS LATER THE PT REQUIRED ADDITIONAL SURGERY TO TREAT A CASE OF ABDOMINAL COMPARTMENT SYNDROME. SEVERAL BLOOD CLOTS WERE DETECTED ALONG THE LOBE OF THE LIVER AND THE LACERATIONS WERE SUTURED WITH ABSORBABLE SUTURES TO ACHIEVE HEMOSTASIS. THE SURGEONS WERE UNABLE TO CLOSE THE WOUND, AND CHOSE TO USE MESH UNTIL GRANULATION TISSUE FORMED THROUGH THE MESH. THE MESH WAS HELD IN PLACE WITH NON-ABSORBABLE SUTURES. THE FOLLOWING MONTH, PT UNDERWENT SKIN GRAFT SURGERY TO CLOSE THE WOUND OVER THE MESH. THE GRAFT REPORTEDLY HEALED PERFECTLY. IT WAS ALSO REPORTED THAT, "IMMEDIATELY AFTER THEIR FIRST SURGERY THE PT EXPERIENCED SYMPTOMS OF INFECTION." IT IS REPORTED THAT PT EXPERIENCED CHRONIC PAIN AND INFECTION UNTIL PT DEATH IN 2001. ALTHOUGH IT WAS REPORTED THAT THE GRAFT HEALED PERFECTLY, IT WAS ALSO STATED THAT THE PT EXPERIENCED AN OPEN WOUND ON THEIR ABDOMEN FROM 1995 THROUGH 2001. PT REQUIRED ANTIBIOTICS, ADDITIONAL SURGERIES, WOUND DEBRIDEMENTS AND IN HOME NURSING CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUT SURGICAL SUTURE SUTURE, ABSORBABLE GAL ETHICON, INC., SAN LORENZO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death