ETHIBOND EXTRA & EXCEL POLYESTER SUTURE

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN INCISIONAL HERNIA PROCEDURE ON (B)(6) 2013 AND SUTURE WAS USED TO SECURE THE GORE DUALMESH IN PLACE. ONE WEEK POST-OPERATIVELY, THE PATIENT RETURNED TO SURGERY TO HAVE THE SURGICAL WOUND WASHED DUE TO AN ABDOMINAL WOUND INFECTION. THE PATIENT WAS READMITTED WITH A TIA AND CELLULITIS OF THE SKIN NEAR THE INCISION. ON (B)(6) 2013, THE PATIENT WAS SEEN IN THE OFFICE WITH SEROMA DRAINAGE AND WOUND SEPARATION WITH FIBRINOUS EXUDATE. ON (B)(6) 2013, THE PATIENT UNDERWENT WOUND EXPLORATION AND SHARP DEBRIDEMENT OF EXTENSIVE AND DEEP FIBRINOUS EXUDATE INCLUDING COVERING OF THE MESH. THE PATIENT IS STABLE POST-OPERATIVE, AND POSSIBLY WILL NEED TO HAVE THE MESH EXPLANTED. CULTURE RESULTS ARE PENDING.

Additional Manufacturer Narrative

(B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.