BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERMACOL 10X15 1.5MM

    MDR report key: 3347325 · Received September 3, 2013

    Report

    Report Number
    9617613-2013-00896
    Event Type
    Death
    Date Received
    September 3, 2013
    Date of Event
    June 30, 2013
    Report Date
    July 8, 2015
    Manufacturer
    COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC
    Product Code
    FTL
    PMA / PMN Number
    K120605
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED 510(K) FROM K992556 TO K120605.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS BEING TREATED OPERATIVELY FOR A RECURRENT INCISIONAL UMBILICAL HERNIA THAT MEASURED 7 CENTIMETERS (CM) X 8 CM. THE WOUND WAS CLASSIFIED AS CLEAN. THE PATIENT WAS UNDER ANESTHESIA FOR 69 MINUTES. THE SURGEON USED AN INTRAPERITONEAL ONLAY PLACEMENT VIA A MODIFIED STOPPA SURGICAL TECHNIQUE. THE MESH WAS FIXATED USING SLOWLY RESORBABLE SUTURES AND AN INTRAPERITONEAL SUBCUTANEOUS DRAIN WAS PLACED AT WOUND CLOSURE. ESTIMATED BLOOD LOSS FOR THE PROCEDURE WAS 20 MILLILITERS (ML). NO SURGICAL COMPLICATIONS WERE EXPERIENCED. AFTER THE DEVELOPMENT OF THE LIVER INSUFFICIENCY AND ENCEPHALOPATHY, THE PATIENT EXPIRED AS A RESULT.

    Description of Event or Problem · 1

    PROCEDURE: HERNIA. ACCORDING TO THE REPORTER: ON (B)(6) 2013, THE PERMACOL MESH WAS IMPLANTED IN THE PT. THE PT WAS DISCHARGE FROM HOSPITAL ON (B)(6) 2013. THEN THE PT RETURNED TO THE HOSPITAL. ON (B)(6) 2013, THE LOCALIZATION SHOWED COMPLETE HEALED ABDOMEN WITH AN INTACT PERMACOL MESH. ON (B)(6) 2013, THE PT DEVELOPED LIVER INSUFFICIENCY WITH ENCEPHALOPATHY. ACCORDING TO THE PRINCIPAL INVESTIGATOR, THE DEVICE HAS DEFINITIVELY NO RELATION TO THE OUTCOME OF THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435362 PERMACOL 10X15 1.5MM PERMACOL MESH FTL COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC 12B12-1

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death NEXIAM (ONGOING), LASIX (ONGOING), SPIRONOLACTONE