BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGISIS HERNIA GRAFT

    MDR report key: 1622489 · Received March 1, 2010

    Report

    Report Number
    1835959-2010-00001
    Event Type
    Injury
    Date Received
    March 1, 2010
    Report Date
    February 22, 2010
    Manufacturer
    COOK BIOTECH, INC.
    Product Code
    FTL
    PMA / PMN Number
    K031850
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (6) 2009 DATE OF INTERVENTION. METHOD: NO DEVICE RETURNED FOR EXAMINATION.

    Description of Event or Problem · 1

    ON (B) (6) 2010, (B) (4) OF RESEARCH AND CLINICAL AFFAIRS FOR COOK BIOTECH INC. CONTACTED DR (B) (6) AND PROVIDED THIS REPORT. THIS CASE WAS A (B) (6) CHILD BROUGHT FROM (B) (6), WHO HAD DRAINING FROM BOTH EARS SINCE AGE 1 (B) (6), TYMPANIC MEMBRANE PERFORATED ON BOTH SIDES, AND WAS ON CONSTANT ANTIBIOTICS (ABX). THE CHILD WAS REFERRED TO DR (B) (6) BY (B) (6). HE WENT AHEAD AND DID A TYMPANOPLASTY WITH SURGISIS ON THE MORE HEALTHY EAR. DR (B) (6) SAID THAT TYPICALLY WHEN SURGISIS IS USED FOR TYMPANOPLASTY IT LOOKS THICK THEN IT THINS OUT, BUT IN THIS KID IT NEVER SEEMED TO THIN OUT, BUT HIS HEARING CAME BACK NORMAL. THE OTHER EAR WAS MORE INFLAMED (LINING OF EAR WAS RED), SO HE SAVED IT FOR LAST (A FEW WEEKS LATER)... AND HE WENT AHEAD AND OPERATED ON IT. THE EAR CANAL BEGAN TO FILL WITH EXTRA TISSUE AND WAS GETTING BIGGER IN THE FIRST FEW WEEKS. IT WAS FILLING THE ENTIRE MIDDLE EAR SPACE. (THE GRAFT IS PLACED BEHIND THE TYMPANIC MEMBRANE AND UNDER THE SKIN OF THE MIDDLE EAR.) DR (B) (6) WENT BACK IN AT ABOUT 4 WEEKS AND FOUND THE GROWTH (B) (6), TOOK THE WHOLE EARDRUM OUT, AND RECONSTRUCTED IT WITH NATIVE FASCIA. THE CHILD COULD STILL HEAR, AND THE GROWTH WAS NOT ATTACHED TO THE BONE. THE BOY GOT CHEMOTHERAPY AFTER THE DIAGNOSIS OF HISTIOCYTOSIS, AND HE ALMOST DIED DUE TO REACTIONS TO THE CHEMO PLUS THE ANTIVIRAL DRUGS. DR (B) (6) SAID NO ONE KNEW THESE DRUGS WOULD REACT THIS WAY, AND HE CLEARLY INDICATED THE CHILD'S DOWNHILL COURSE WAS DUE TO DRUG REACTIONS (THE CHILD IS DOING BETTER NOW).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGISIS HERNIA GRAFT SURGICAL MESH 21CFR PART 878.3300 FTL COOK BIOTECH, INC. G31320 LB421352

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention NONE KNOWN