D
Patient 1
IT WAS REPORTED TO THE COMPANY ON (B)(6) 2017 THAT A PATIENT WHO HAD UNDERWENT AN ABDOMINOPLASTY SURGERY USING TISSUGLU? SURGICAL ADHESIVE IN CONJUNCTION WITH STANDARD OF CARE ON (B)(6) 2017 HAD A MINOR COMPLICATION ON (B)(6) 2017. ON (B)(6) 2017 THE SURGEON NOTIFIED COHERA MEDICAL THAT THE PATIENT HAD REQUIRED A PROCEDURE TO OPEN A RAISED SURFACE AREA, DESCRIBED AS AN ABSCESS, ALONG THE INCISION LINE. ON (B)(6) 2017 THE RAISED SURFACE AREA WAS OPENED, BY THE PHYSICIAN, USING A MINOR PROCEDURE IN THE OR AND AN ALLEGED SMALL AMOUNT OF RESIDUAL TISSUGLU? SURGICAL ADHESIVE WAS REMOVED USING FORCEPS. THE REPORTED CONDITION ON THE ABDOMEN CAN BE A PRECURSOR TO EXTRUSION AND THEREFORE IS CONSISTENT WITH KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH ABDOMINOPLASTY SURGERIES AND IS DESCRIBED AS A PRECAUTION IN THE TISSUGLU SURGICAL ADHESIVE DIRECTIONS FOR USE ((B)(4)): "CONSIDERATION SHOULD BE TAKEN IN THE USE OF TISSUGLU?, AS THERE IS A POSSIBILITY THAT CURED TISSUGLU? MAY BE EXTRUDED SIMILAR TO SUTURE EXTRUSION. FURTHER COMMUNICATION ON (B)(6) 2017 BETWEEN COHERA AND THE PHYSICIAN AND STAFF FIND THAT THE PATIENT'S CONDITION WAS RESOLVED AND REQUIRED NO ADDITIONAL INTERVENTION AFTER THE ADDITIONAL PROCEDURE PERFORMED ON (B)(6) 2017.