ETHIBOND EXTRA & EXCEL POLYESTER SUTURE

Additional Manufacturer Narrative

(B)(4). CONCLUSION: 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.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL CORD STIMULATOR IMPLANT PROCEDURE ON AN UNKNOWN DATE. THE STAFF NOTED A GREENISH YELLOW OR LIME GREEN DISCHARGE FROM THE INCISION WHEN PERFORMING ONE OF THE EARLY DRESSING CHANGES. CULTURES WERE SENT AND NO GROWTH WAS NOTED. THE PATIENT WAS CHECKED FOR SIGNS OF INFECTION. THERE WAS NO SWELLING, REDNESS OR HEAT AND THERE WAS NO TISSUE SOFTNESS OR SPONGINESS. WHEN THE STAPLES WERE REMOVED FROM THE INCISION, THE INCISION HAD HEALED AND THERE WAS NO DELAY IN HEALING TIME.