BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROLENE POLYPROPYLENE MESH

    MDR report key: 488315 · Received October 10, 2003

    Report

    Report Number
    2210968-2003-00401
    Event Type
    Death
    Date Received
    October 10, 2003
    Date of Event
    December 4, 2001
    Report Date
    September 10, 2003
    Manufacturer
    ETHICON, INC. SAN LORENZO
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT SURGERY FOR VAGINAL PROLAPSE REPAIR IN 2001 IN WHICH BONE ANCHORS AND A FASCIAL SLING WERE UTILIZED WITH A MESH PRODUCT. A WEEK LATER PT'S STATUS CHANGED. THE PT WAS NOTED TO BE HYPOTENSIVE, OLIGURIC, AND WITH SYMPTOMS OF AN ACUTE ABDOMEN. PT WAS ALSO HYPOXIC, WENT INTO RESPIRATORY FAILURE AND SHOWED A PLEURAL EFFUSION. PT WAS PUT ON A DOPAMINE DRIP AND INTUBATED. THE DIAGNOSIS AT THAT TIME WAS SEPSIS/RULE OUT ABDOMINAL CATASTROPHE. BLOOD CULTURE RESULTS WERE REPORTED TO BE CONFLICTING. SAME DAY PT HAD A LAPAROTOMY REVISION OF THE ILEUM. THE REMOVED MESH SPECIMENS SHOWED A PATHOLOGY RESULT OF "FILTRATION WITH FUNGAL SPORES, MOST LIKELY ASPERGILLUM, BUT A MIXED FUNGAL POPULATION IS NOT EXCLUDED." PT WAS TREATED WITH DRUG THERAPY. PT DID NOT IMPROVE WITH SURGERY AND ULTIMATELY DIED. NO AUTOPSY WAS PERFORMED. NO CAUSE OF DEATH IS OTHERWISE LISTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLENE POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. SAN LORENZO NA PBE804

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death FASCIAL SLING, BONE ANCHORS.