A REVIEW OF THE DEVICE LOT HISTORY RECORDS INDICATED THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. THE DEVIATION WOULD NOT HAVE CONTRIBUTED TO THE REPORTED OCCURRENCE. A TOTAL OF TWO (2) DEVICES WAS PRODUCED FROM THE LOT. A REVIEW OF THE CBI COMPLAINT DATABASE DID NOT REVEAL ANY ADDITIONAL COMPLAINTS INVOLVING THE REPORTED LOT NUMBER. A REVIEW OF THE IFU INDICATED THAT SEROMA FORMATION AND INFECTION (IRRESPECTIVE OF ONE ANOTHER) ARE NOTED IN THE POTENTIAL COMPLICATIONS AS SOME OF THE "POSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY PROSTHESIS." IN ADDITION, THE IFU NOTES THAT ?COMPLICATIONS, SUCH AS DELAYED WOUND INFECTION, PREMATURE DEGRADATION, HERNIA RECURRENCE, BOWEL EROSION, AND THE NEED FOR RE-OPERATION, SHOULD BE REASONABLY EXPECTED IN PATIENTS WHO ARE CRITICALLY ILL OR WHO HAVE SEVERELY CONTAMINATED ABDOMENS." THE ROOT CAUSE OF THE SEROMA IS LIKELY RELATED TO THE EXTENSIVE DISRUPTION OF TISSUE THAT OCCURRED DURING THE SURGICAL PROCEDURE. HOWEVER, SEROMA FORMATION IS A KNOWN INHERENT RISK OF THE SURGICAL PROCEDURE AND IS A KNOWN POTENTIAL OUTCOME WITH THE USE OF ANY PROSTHESIS.
D
Patient 1
ON (B)(6) 2017, DR. (B)(6) PLACED A C-SLH-8H-20X30 IN A (B)(6) MALE PATIENT. THE PATIENT HAD A PRIOR PLACEMENT OF POLYPROPYLENE MESH WHICH BECAME INFECTED. THE INFECTED POLYPROPYLENE WAS REMOVED BY LAPAROSCOPY AND THE BIODESIGN HERNIA GRAFT WAS PLACED IN AN OPEN PROCEDURE. THE BIODESIGN WAS PLACED FOR REPAIR OF A VENTRAL HERNIA. SEROMA FLUID WAS DRAINED FOR APPROXIMATELY 28-30 DAYS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ONCE THE DRAIN OUTPUT WAS BELOW 20 ML PER DAY. TWO (2) WEEKS LATER, APPROXIMATELY FIFTY (50) DAYS POST BIODESIGN PLACEMENT, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO FEVER AND SEROMA FORMATION. THE SEROMA WAS UNABLE TO BE DRAINED DUE TO THICKNESS AND THE PATIENT UNDERWENT ADDITIONAL SURGERY TO ASSESS FOR INFECTION AND SEROMA. THE SEROMA WAS DESCRIBED AS THICK, 300 ML FLUID COLLECTION, AND A CAUSE WAS UNABLE TO BE FOUND. A TISSUE SPECIMEN WAS SENT FOR LABORATORY REVIEW.