BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIODESIGN SURGISIS HERNIA GRAFT

    MDR report key: 1943837 · Received December 22, 2010

    Report

    Report Number
    1835959-2010-00007
    Event Type
    Other
    Date Received
    December 22, 2010
    Date of Event
    October 21, 2010
    Report Date
    December 21, 2010
    Manufacturer
    COOK BIOTECH
    Product Code
    FTL
    PMA / PMN Number
    K073391
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - NO DEVICE RETURNED FOR EXAMINATION. COOK BIOTECH BELIEVES THAT POSSIBLY THE HERNIA SACK WAS NOT CLOSED COMPLETELY DURING THE INITIAL PROCEDURE. THIS LED TO A SEROMA FORMATION WHICH INHIBITED THE REMODELING DUE TO THE FACT THAT THE PRODUCT WAS THEN NOT ATTACHED TO VASCULARIZED TISSUE WHICH IS NECESSARY FOR TISSUE INCORPORATION. THIS CAUSED THE SLOUGHING OF THE MATERIAL WHICH WAS SEEN DURING THE RE-OPERATION. PT MAY ALSO HAVE HAD A REACTION TO THE LARGE NUMBER OF TACKS THAT WERE PLACED IN THE ABDOMEN. COOK BIOTECH ALSO BELIEVES THAT THE INFECTION WAS LIKELY INTRODUCED DURING THE PROCEDURE THAT WERE PERFORMED TO DRAIN THE SEROMA. THE DOCTOR CONCURRED THAT WAS LIKELY THE CASE. SEROMA FORMATION IS LISTED AS A POSSIBLE COMPLICATION IN THE IFU.

    Description of Event or Problem · 1

    THE PT HAD AN UMBILICAL DIASTASIS. DR. (B)(6) REPAIRED THIS PT LAPAROSCOPICALLY WITH A LARGE BIODESIGN SHEET WITH SEVERAL CENTIMETERS OF OVERLAP IN ALL DIRECTIONS. HE STATED THAT HE USED APPROX THREE GUNS WORTH OF METAL TACKS TO HOLD IT IN PLACE, WITH TACKED EVERY COUPLE OF CENTIMETERS. AFTER 4 MONTHS, THE PT CAME BACK WITH PAIN AND INDURATION IN THE HERNIA REPAIR REGION, EVEN THOUGH NO PROBLEMS WERE REPORTED BEFORE THIS POINT. THE DOCTOR ORDERED A CT WHICH REVEALED A LARGE SEROMA NEAR THE GRAFT. DR. (B)(6) TAPPED THE SEROMA TO DRAIN IT (ROUGHLY 1.5L) AND SENT THE PT HOME. THE PT CAME BACK A SECOND TIME WITH THE SAME COMPLAINTS, AND THE DOCTOR PLACED A DRAIN IN THE SEROMA CAVITY THIS TIME. THE SEROMA REFILLED AND BECAME INFECTED. DR. (B)(6) TOOK THE PT BACK TO THE OPERATING ROOM TO DO A SITE DEBRIDEMENT AND REPAIR. WHAT HE FOUND WAS A LAYER OF WHAT APPEARED TO BE HEALED TISSUE COVERING THE FLUID SACK. WHEN THE SACK WAS OPENED IT DRAINED A LARGE AMOUNT OF MUCOID-LOOKING, TURBULENT FLUID (NEARLY 2.5L) AND CONTAINED FAIRLY LARGE SHEETS OR STRIPS OF WHAT APPEARED TO BE UNINCORPORATED SIS. THE PT'S CONDITION IS UNK AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIODESIGN SURGISIS HERNIA GRAFT COMPLEX HERNIA GRAFT EXL FTL COOK BIOTECH G48216 LB447592

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R ANTIBIOTICS. THE TYPES AND DATES OF THERAPY ARE| UNK TO THE MFR.| PT WAS STARTED ON TWO DIFFERENT TYPES OF