ETHIBOND EXTRA & EXCEL POLYESTER SUTURE

Additional Manufacturer Narrative

(B)(4): IT WAS REPORTED THAT A PATIENT UNDERWENT A MODIFIED HYOID SUSPENSION PROCEDURE ON (B)(6) 2011 AND SUTURE WAS USED ON THE TONGUE AND FIRST MAXILLA. EIGHT DAYS AFTER THE PROCEDURE, THE PATIENT'S WOUND HAD AN INFECTION. INTERVENTION WAS REQUIRED. THE PATIENT IS CURRENTLY FINE. FOUR RETURNED EXPLANTED GREEN BRAIDED SUTURES WERE MICROSCOPICALLY EXAMINED. THE FOUR RETURNED EXPLANTED SEGMENTS WERE BETWEEN 5-9CM IN LENGTH AND BOTH ENDS OF EACH EXPLANTED SUTURE WAS CUT. RESIDUAL BLOOD AND TISSUE REMAINS WERE PRESENT ON ALL FOUR RETURNED SUTURE SEGMENTS. THE RETURNED SUTURE WAS USED, THEREFORE NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT A LINGUAL ROOT IMPROVEMENT DRAG SURGERY ON (B)(6) 2011 AND SUTURE WAS USED ON THE TONGUE AND FIRST MAXILLA. EIGHT DAYS AFTER THE PROCEDURE, THE PATIENT'S WOUND HAD HYPEREMIA, EDEMA, EXUDATION AND HYPERBLASTOSIS. THE SURGEON OBSERVED AND EXCISED THE GRANULATION. CURRENTLY, THE PATIENT'S WOUND IS HEALING.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: THE PATIENT'S CONDITION HAS STILL NOT IMPROVED AND HAS BECOME AGGRAVATED. A SECOND SURGERY WAS PERFORMED WITHOUT ANY IMPROVEMENT. ON (B)(6) 2013 A THIRD SURGERY WAS PERFORMED. NO ADDITIONAL INFORMATION HAS BEEN GIVEN AT THIS TIME.

Additional Manufacturer Narrative

(B)(4): THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.