Description of Event or Problem · 1
GRANULOMAS/ GRANULOMATOUS AND FOCALLY NECROTIZING FOREIGN BODIES [GRANULOMA]. PERSISTENT PAIN [PAIN]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON (B)(6) 2010 FROM A HEALTH CARE PROVIDER, REGARDING A FEMALE PT. THE PT HAD A HISTORY OF SUCCESSFUL IN-VITRO FERTILIZATION FIVE YRS PRIOR TO THE DATE OF THIS REPORT AND PERSISTENT RIGHT OVARIAN CYSTS. THE PT EXPERIENCED PERSISTENT PAIN AND GRANULOMAS AFTER RECEIVING SEPRAFILM. ON AN UNSPECIFIED DATE, THE PT RECEIVED SEPRAFILM. THE HCP REPORTED THE PT HAD GYNECOLOGICAL SURGERY AND FLOSEAL PRODUCT WAS USED TO ASSIST WITH ACHIEVING HEMOSTASIS. THE PT RETURNED TO SURGERY A FEW WEEKS LATER FOR PERSISTENT PAIN AND WAS FOUND TO HAVE GRANULOMATOUS AND FOCALLY NECROTIZING FOREIGN BODIES. THE PATHOLOGY REPORT CONFIRMED MULTIPLE GRANULOMAS NEGATIVE FOR MALIGNANCY. THE SURGEON BELIEVED THE PT HAD A REACTION TO THE PRODUCT. THE GENERAL SURGEON WHO PERFORMED THE SECOND SURGERY, WHEN THE PT RETURNED COMPLAINING OF PAIN, BELIEVED THE GRANULOMAS TO BE A REACTION FROM THE PRODUCT. THE PT'S ADVERSE EVENT DID NOT INVOLVE AN ELECTROPHYSIOLOGY PROCEDURE OR AN ATTEMPTED ELECTROPHYSIOLOGY PROCEDURE. THE ORIGINAL INTENDED PROCEDURE WAS THE USE OF PRODUCT TO ASSIST WITH OOZING OVER AREAS OF SURGICAL DISSECTION DURING OPERATIVE PROCEDURE. AT THE TIME OF THIS REPORT, THE OUTCOME OF THE PT WAS UNK. THE LOT NUMBER WAS REPORTED TO BE 09NP173. NO ADDITIONAL INFO WAS PROVIDED.