TEPHAFLEX MESH

Description of Event or Problem

PHYSICIAN PERFORMED A SMAS SURGICAL PROCEDURE ON (B)(6) 2012. SEVEN MONTHS POST-PROCEDURE, THE PT RETURNED TO THE PHYSICIAN¿S OFFICE WITH A REDDENED AREA THAT WAS PAINFUL TO THE TOUCH. UPON EXAMINATION IT WAS FOUND THAT APPROXIMATELY 1CM MESH WAS EXTRUDING WITH INDICATIONS OF INFECTION. ALTHOUGH THE INFECTION WAS NOT CONFIRMED WITH CULTURES, THE PHYSICIAN PRESCRIBED A 7 DAY CYCLE OF DOXYCYCLINE FOR THE INFECTION. THE INCISION WAS REOPENED, CLEANED, AND RE-CLOSED AT THE ORIGINAL SURGICAL SITE. A DAY AFTER THE VISIT ON (B)(6) 2012, THE PHYSICIAN NOTED THAT THE PT HAD LESS PAIN, LITTLE REDNESS, AND THE WOUND LOOKED GOOD. ON (B)(6) 2012, THE PHYSICIAN NOTED THE PT AS BEING SIGNIFICANTLY BETTER.

Additional Manufacturer Narrative

THE MFG RECORDS FOR LOT 110311 WERE REVIEWED AND THERE IS NO EVIDENCE TO SUGGEST THE DEVICES MAY HAVE BEEN RELEASED WITH NONCONFORMITIES RELATED TO THE NATURE OF THIS EVENT. A VERY SMALL PIECE OF MESH WAS RETURNED OF LESS THAN 1CM, WHICH WAS TOO SMALL TO EVALUATE. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. THE PT ATTENDED A FOLLOW-UP VISIT ON (B)(6) 2012, APPROX 3 WEEKS AFTER THE INTERVENTION AT WHICH TIME THE SURGEON RECORDED THAT THE SURGICAL INCISION SITE WAS INTACT AND THERE WAS NO ERYTHEMA. THE PHYSICIAN CONSIDERS THIS ADVERSE EVENT TO BE RESOLVED.